2017 First Generic Drug Approvals
Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients.
“First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions.
Note: Approved drugs are not always available on or after the listed approval date. Please contact the listed ANDA applicant for more information about a drug product’s availability.
First-Time Generic Drug Approvals 2017*
| ANDA Number | Generic Name | ANDA Applicant | Brand Name | ANDA Approval Date | ANDA Indication+ | |
|---|---|---|---|---|---|---|
| 80 | 208788 | Estradiol Vaginal Cream USP, 0.01% | Mylan Pharmaceuticals Inc. | Estrace (Estradiol) Vaginal Cream, USP, 0.01% | 12/29/2017 | Indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause |
| 79 | 207313 | Butalbital and Acetaminophen Capsules, 50 mg/300 mg | Mikart, Inc. | Phrenilin Forte (Butalbital and Acetaminophen) Capsules, 50 mg/650 mg | 12/27/2017 | Indicated for the relief of the symptom complex of tension (or muscle contraction) headache |
| 78 | 078064 | Efavirenz Capsules USP, 50 mg, 100 mg, and 200 mg | Aurobindo Pharma Limited | Sustiva Capsules (Efavirenz Capsules), 50 mg, 100 mg, and 200 mg | 12/15/2017 | Indicated for the treatment of HIV-1 infection |
| 77 | 207550 | Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL vials, 200 mg/5 mL (40 mg/mL) Multi-dose vials and 400 mg/10 mL (40 mg/mL) Multi-dose vials | Amneal Pharmaceuticals Company GmbH | Kenalog (Triamcinolone Acetonide)-40 Injection, USP, 40 mg/mL vials, 200 mg/5 mL (40 mg/mL) Multi-dose vials and 400 mg/10 mL (40 mg/mL) Multi-dose vials | 12/13/2017 | For use as an injectable corticosteroid therapy |
| 76 | 208518 | Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets, 10 mg/10 mg | Par Pharmaceutical, Inc. | Diclegis (Doxylamine Succinate and Pyridoxine Hydrochloride) Delayed-Release Tablets, 10 mg/10 mg | 12/6/2017 | Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management |
| 75 | 209235 | Ibuprofen and Pseudoephedrine Hydrochloride Capsules, 200 mg/ 30 mg (OTC) | Aurobindo Pharma Limited | Advil Cold and Sinus (Ibuprofen and Pseudoephedrine Hydrochloride) Liqu-Gels, 200 mg/ 30 mg (OTC) | 12/1/2017 | Indicated for the temporary relieve of symptoms associated with the common cold and flu |
| 74 | 209102 | Baclofen Tablets USP, 5 mg | Rubicon Research Private Limited | Lioresal (Baclofen)Tablets, 5 mg | 11/28/2017 | Indicated for use in the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity |
| 73 | 208820 | Praziquantel Tablets USP, 600 mg | Par Pharmaceutical, Inc. | Biltricide (Praziquantel) Tablets, 600 mg | 11/27/2017 | Indicated for the treatment of infections due to: all species of Schistosoma and infections due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini |
| 72 | 202634 | Capreomycin for Injection USP, 1 gram per vial | Mylan Laboratories Limited | Capastat Sulfate (Capreomycin) for Injection, 1 gram/vial | 11/27/2017 | Indicated to be used concomitantly with other appropriate antituberculosis agents, in pulmonary infections caused by capreomycin-susceptible strains of M. tuberculosis when the primary agents (isoniazid, rifampin, ethambutol, aminosalicylic acid, and streptomycin) have been ineffective or cannot be used because of toxicity or the presence of resistant tubercle bacilli. Susceptibility studies should be performed to determine the presence of a capreomycin susceptible strain of M. tuberculosis |
| 71 | 207382 | Topiramate Extended-Release Capsules, 25 mg, 50 mg, and 100 mg | Zydus Pharmaceuticals (USA), Inc | Trokendi (Topiramate) XR Extended-Release Capsules | 11/24/2017 | For the treatment of: monotherapy epilepsy: initial monotherapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy epilepsy: adjunctive therapy in patients 6 years of age and older with partial onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome; migraine: prophylaxis of migraine headache in adults and adolescents 12 years of age and older |
| 70 | 209556 | Hydrocortisone Butyrate Lotion, 0.1% | Teligent Pharma, Inc. |
Locoid (Hydrocortisone Butyrate) Lotion, 0.1% | 11/21/2017 | Indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older |
| 69 | 202118 | Darunavir Tablets, 600 mg | Teva Pharmaceuticals USA, Inc. | Prezista (Darunavir) Tablets, 600 mg | 11/21/2017 | Indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older |
| 68 | 209695 | Fluoxetine Tablets USP, 60 mg | Inventia Healthcare Private Limited | Fluoxetine Tablets, 60 mg | 11/20/2017 | Indicated for the treatment of major depressive disorder (MDD), obsessive compulsive disorder (OCD), bulimia nervosa, and panic disorder, with or without agoraphobia |
| 67 | 207338 | Fentanyl Sublingual Tablets, 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, and 800 mcg | Actavis Laboratories FL, Inc. | Abstral (Fentanyl) Sublingual Tablets, 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, and 800 mcg | 11/17/2017 | For the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain |
| 66 | 209419 | Fluoxetine Tablets USP, 60 mg | Par Pharmaceuticals, Inc. | Fluoxetine Tablets, 60 mg | 11/16/2017 | Indicated for the treatment of major depressive disorder (MDD), obsessive compulsive disorder (OCD), bulimia nervosa, and panic disorder, with or without agoraphobia |
| 65 | 205181 | Butenafine Hydrochloride Cream, 1% | Taro Pharmaceuticals USA Inc. | Lotrimin (Butenafine Hydrochloride) Ultra Cream, 1% | 11/16/2017 | Indicated for the treatment of Athlete’s Foot and Jock Itch |
| 64 | 206687 | Sodium Acetate Injection USP, 400 mEq/100 mL (4 mEq/mL) | Fresenius Kabi USA, LLC | Sodium Acetate Injection USP, 400 mEq/100 mL (4 mEq/mL) | 10/30/2017 | Indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions |
| 63 | 208306 | Methadone Hydrochloride Injection USP, 200 mg/20 mL (10 mg/mL) multiple dose vial | Akorn, Inc. | Methadone Hydrochloride Injection USP, 200 mg/20 mL (10 mg/mL) multiple dose vial | 10/27/2017 | For the management of pain severe enough to require an opioid analgesic and for which alternative treatment options are inadequate; for use in temporary treatment of opioid dependence in patients unable to take oral medication |
| 62 | 090132 | Carvedilol Phosphate Extended-Release Capsules, 10 mg, 20 mg, 40 mg and 80 mg |
|
Coreg CR (Carvedilol Phosphate) Extended-Release Capsules, 10 mg, 20 mg, 40 mg and 80 mg |
10/25/2017 | Indicated for the treatment of hypertension |
| 61 | 209662 | Potassium Chloride for Oral Solution USP, 20 mEq | Upsher-Smith Laboratories, Inc. | Klor-Con® Powder (Potassium Chloride for Oral Solution USP) , 20 mEq | 10/23/2017 | For treatment of potassium deficiency |
| 60 | 209506 | Dapsone Gel, 5% | Taro Pharmaceuticals USA Inc. | Aczone (Dapsone) Gel, 5% | 10/16/2017 | For the topical treatment of acne vulgaris |
| 59 | 202934 | Dextromethorphan Hydrobromide and Quinidine Sulfate Capsules, 10 mg/20 mg | Actavis Elizabeth LLC | Nuedexta (Dextromethorphan Hydrobromide and Quinidine Sulfate) Capsules, 10 mg/20 mg | 10/10/2017 | Indicated for the treatment of pseudobulbar affect (PBA) |
| 58 | 206936 | Glatiramer Acetate Injection, 40 mg/ml | Mylan Pharmaceuticals Inc. | Copaxone (Glatiramer Acetate) Injection, 40 mg/ml | 10/3/2017 | Indicated for the treatment of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis |
| 57 | 207650 | Caspofungin Acetate for Injection, 50 mg (base)/vial and 70 mg (base)/vial, Single Dose Vials | Mylan Laboratories Limited | Cancidas (Caspofungin Acetate) Injection, 50 mg (base)/vial and 70 mg (base)/vial, Single Dose Vials | 9/29/2017 | For treatment in adults and pediatric patients (3 months of age and older) for: empirical therapy for presumed fungal infections in febrile, neutropenic patients, treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections, treatment of esophageal candidiasis, or the treatment of invasive aspergillosis in patients wo are refractory to or intolerant of other therapies |
| 56 | 207092 | Caspofungin Acetate for Injection, 50 mg (base)/vial and 70 mg (base)/vial, Single Dose Vials | Gland Pharma Limited | Cancidas (Caspofungin Acetate) Injection, 50 mg (base)/vial and 70 mg (base)/vial, Single Dose Vials | 9/29/2017 | For treatment in adults and pediatric patients (3 months of age and older) for: empirical therapy for presumed fungal infections in febrile, neutropenic patients, treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections, treatment of esophageal candidiasis, or the treatment of invasive aspergillosis in patients wo are refractory to or intolerant of other therapies |
| 55 | 204398 | Pilocarpine Hydrochloride Ophthalmic Solution USP, 1%, 2% and 4% | Akorn Inc. | Isopto Carpine (Pilocarpine Hydrochloride) Ophthalmic Solution USP, 1%, 2% and 4% | 9/27/2017 | For the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, the management of acute angle-closure glaucoma, the prevention of postoperative elevated IOP associated with laser surgery, or the induction of miosis |
| 54 | 091073 | Testosterone Gel, 1% | Actavis Laboratories UT, Inc. | Testim (Testosterone) Gel, 1% | 9/18/2017 | For testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone; primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired) |
| 53 | 209113 | Oseltamivir Phosphate for Oral Suspension, 6 mg (base)/mL | Nesher Pharmaceuticals (USA) LLC | Tamiflu (Oseltamivir Phosphate) for Oral Suspension, 6 mg (base)/mL | 9/14/2017 | For the treatment of the flu (influenza A and B) in patients two weeks of age and older who have had flu symptoms for no more than 48 hours, and prevention of the flu in patients one year of age and older |
| 52 | 207563 | Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) Single-Dose Vial; 80 mg/8 mL and 160 mg/16 mL (10 mg/mL) Multi-Dose Vial (one-vial formulation) | Ingenus Pharmaceuticals, LLC | Docetaxel Injection, 20 mg/2 mL (10 mg/mL) Single-Dose Vial; 80 mg/8 mL and 160 mg/16 mL (10 mg/mL) Multi-Dose Vial (one-vial formulation) | 8/31/2017 | For treatment of breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, squamous cell carcinoma of the head, and neck cancer |
| 51 | 203900 | Tacrolimus Injection, 5 mg/mL, 1 mL Single-Dose Vial | Hospira, Inc. | Prograf (Tacrolimus) Injection, 5 mg/mL, 1 mL Single-Dose Vial | 8/25/2017 | For prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants |
| 50 | 209784 | Ephedrine Sulfate Injection USP, 50 mg/mL Single-Dose Vial | Sandoz Inc. | Akovaz (Ephedrine Sulfate) Injection USP, 50 mg/mL Single-Dose Vial | 8/23/2017 | For the treatment of clinically important hypotension occurring in the setting of anesthesia |
| 49 | 207193 | Esomeprazole Magnesium Delayed-Release Capsules, 20 mg (OTC) | Perrigo R&D Company | Nexium 24HR (Esomeprazole Magnesium) Delayed-Release Capsules, 20 mg (OTC) | 8/18/2017 | For the treatment of frequent heartburn (occurs 2 or more days a week) |
| 48 | 090978 | Lanthanum Carbonate Chewable Tablets, 500 mg (base), 750 mg (base), 1000 mg (base) | Natco Pharma Limited | Fosrenol (Lanthanum Carbonate) Chewable Tablets, 500 mg (base), 750 mg (base), 1000 mg (base) | 8/11/2017 | To reduce serum phosphate in patients with end stage renal disease (ESRD) |
| 47 | 207252 | Docetaxel Injection USP, 160 mg/8 mL (20 mg/mL) Single-Dose Vial (one-vial formulation) | Jiangsu Hengrui Medicine Co., Ltd. | Taxotere (Docetaxel) Injection Concentrate, 160 mg/8 mL (20 mg/mL) Single-Dose Vial (one-vial formulation) | 8/9/2017 | For treatment of breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, squamous cell carcinoma of the head, and neck cancer |
| 46 | 206961 | Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) (single-dose vials) | Nexus Pharmaceuticals, Inc. | Isuprel (Isoproterenol Hydrochloride) Injection, 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) (single-dose vials) | 8/2/2017 | For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy; serious episodes of heart block and Adams-Stokes attacks, congestive heart failure, cardiogenic shock, and other serious issues |
| 45 | 209088 | 10% Calcium Chloride Injection USP, 1 gram/10 mL (100 mg/mL) single-dose vial | Luitpold Pharmaceuticals, Inc. | 10% Calcium Chloride Injection, 1 gram/10 mL (100 mg/mL) single-dose vial | 7/27/2017 | For the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels |
| 44 | 208092 | Minoxidil Topical Aerosol, 5% (For Women) | Watson Laboratories, Inc. | Women's Rogaine (Minoxidil) Topical Aerosol, 5% | 7/27/2017 | To regrow hair on the top of the scalp |
| 43 | 203286 | Mesalamine Delayed-Release Tablets USP, 800 mg | Zydus Pharmaceuticals (USA) Inc. | Asacol HD (Mesalamine) Delayed-Release Tablets USP, 800 mg | 7/21/2017 | For the treatment of moderately active ulcerative colitis in adults |
| 42 | 207179 | Sevelamer Carbonate Tablets, 800 mg | Aurobindo Pharma Limited | Renvela (Sevelamer Carbonate) Tablets, 800 mg | 7/17/2017 | For the control of serum phosphorus in adults with chronic kidney disease on dialysis |
| 41 | 205927 | Prasugrel Tablets, 5 mg, 10 mg | Mylan Pharmaceuticals | Effient (Prasugrel) Tablets, 5 mg, 10 mg | 7/12/2017 | A P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in certain patients with acute coronary syndrome who are to be managed with PCI |
| 40 | 205781 | Testosterone Topical Gel 1.62% (20.25 mg/ 1.25 g packet), 1.62% (40.5 mg/ 2.6 g packet) | Perrigo UK Finco Limited Partnership | Androgel (Testosterone) Topical Gel 1.62% (20.25 mg/ 1.25 g packet), 1.62% (40.5 mg/ 2.6 g packet) | 7/12/2017 | For replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired) |
| 39 | 201751 | Ultacan (Articaine Hydrochloride and Epinephrine) Injection, USP 4%/ 1:200,000 | Hansamed, Inc. | Septocaine (Articaine Hydrochloride and Epinephrine) Injection, 4%/ 1:200,000 | 7/11/2017 | For local, infiltrative, or conductive anesthesia in both simple and complex dental procedures |
| 38 | 204663 | Phentermine Hydrochloride Orally Disintegrating Tablets, 15 mg, 30 mg, 37.5 mg |
Zydus Pharmaceuticals (USA) Inc. | Suprenza (Phentermine Hydrochloride) Orally Disintegrating Tablets, 15 mg, 30 mg, 37.5 mg | 6/28/2017 |
For use as a short-term adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for certain patients |
| 37 | 207139 | Paroxetine Capsules, 7.5 mg | Actavis Laboratories FL, Inc. | Brisdelle (Paroxetine) Capsules, 7.5 mg | 6/20/2017 | For the treatment of moderate to severe vasomotor symptoms associated with menopause |
| 36 | 208765 | Doxycycline Hyclate Tablets USP, 75 mg, 150 mg | Mayne Pharma, Inc. | Acticlate (Doxycycline Hyclate) Tablets, 75 mg, 150 mg | 6/14/2017 | For treatment of rickettsial, sexually transmitted, respiratory tract, ophthalmic, and specific bacterial infections; anthrax, including inhalational anthrax (post-exposure); alternative treatment for selected infections when penicillin is contraindicated; adjunctive therapy for acute intestinal amebiasis and severe acne; and prophylaxis of malaria |
| 35 | 207624 | Sevelamer Carbonate Powder for Oral Suspension, 0.8 g, 2.4 g | Aurobindo Pharma Limited | Renvela (Sevelamer Carbonate) Powder for Oral Suspension, 0.8 g, 2.4 g | 6/13/2017 | For the control of serum phosphorus in adults with chronic kidney disease on dialysis |
| 34 | 090894 | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg | Teva Pharmaceuticals USA | Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) Tablets, 200 mg/300 mg | 6/8/2017 | For the treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk. For treatment in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg |
| 33 | 091640 | Mesalamine Delayed-Release Tablets USP, 1.2 g | Zydus Pharmaceuticals (USA) Inc. | Lialda (Mesalamine) Delayed-Release Tablets USP, 1.2 g | 6/5/2017 | For the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis |
| 32 | 79019 | Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg | Glenmark Pharmaceuticals Limited | Strattera (Atomoxetine) Capsules USP,10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg | 5/30/2017 | For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD) |
| 31 | 79016 | Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg | Aurobindo Pharma Limited | Strattera (Atomoxetine) Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg | 5/30/2017 | For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD) |
| 30 | 79022 | Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg | Teva Pharmaceuticals USA | Strattera (Atomoxetine) Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg | 5/30/2017 | For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD) |
| 29 | 78983 | Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg | Apotex, Inc. | Strattera (Atomoxetine) Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg | 5/30/2017 | For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD) |
| 28 | 077337 | Rosiglitazone Maleate and Metformin Hydrochloride Tablets, 1 mg (base)/500 mg | Teva Pharmaceuticals | Avandamet (Rosiglitazone Maleate and Metformin Hydrochloride) Tablets, 1 mg (base)/500 mg | 5/19/2017 | For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus |
| 27 | 204029 | Moxifloxacin Hydrochloride in Sodium Chloride 0.8% Solution, 400 mg/250 mL (1.6 mg/mL) in 250 mL single-dose flexible bags | Mylan Laboratories Limited | Avelox (Moxifloxacin Hydrochloride in Sodium Chloride 0.8%) Solution, 400 mg/250 mL (1.6 mg/mL) in 250 mL single-dose flexible bags | 5/5/2017 | For the treatment of infections caused by designated, susceptible bacteria |
| 26 | 090681 | Clofarabine Injection, 20 mg/20 mL (1 mg/mL) Single-Use Vial | Abon Pharmaceuticals, LLC | Clolar (Clofarabine) Injection, 20 mg/20 mL (1 mg/mL) Single-Use Vial | 5/9/2017 | For the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens |
| 25 | 206260 | Quetiapine Fumarate Extended-Release Tablets, 150 mg, 200 mg, 300 mg | Accord Healthcare Inc. | Seroquel XR (Quetiapine Fumarate) Extended-Release, 150 mg, 200 mg, 300 mg | 5/9/2017 | For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants |
| 24 | 090482 | Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg | Pharmadax Inc. | Seroquel XR (Quetiapine Fumarate) Extended-Release), 50 mg, 150 mg, 200 mg, 300 mg, 400 mg | 5/9/2017 | For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants |
| 23 | 202939 | Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg | Par Pharmaceutical Inc. | Seroquel XR (Quetiapine Fumarate) Extended-Release, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg | 5/9/2017 | For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants |
| 22 | 205833 | Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg | IntelliPharmaCeutics Corp. | Seroquel XR (Quetiapine Fumarate) Extended-Release, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg | 5/9/2017 | For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants |
| 21 | 207712 | Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, 137mcg/50mcg | Apotex Inc. | Dymista (Azelastine Hydrochloride and Fluticasone Propionate) Nasal Spray, 137mcg/50mcg | 4/28/2017 | For treatment of allergic rhinitis |
| 20 | 208218 | Vigabatrin for Oral Solution USP, 500mg per packet | Par Pharmaceutical, Inc. | Sabril (Vigabatrin) for Oral Solution USP, 500mg per packet | 4/27/2017 | For treatment in refractory complex partial seizures as adjunctive therapy in patients ≥10 years of age who have responded inadequately to several alternative treatments. For treatment of infantile spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss |
| 19 | 201890 | Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg | Impax Laboratories Inc. |
Vytorin (Ezetimibe and Simvastatin), 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg | 4/26/2017 | For use as adjunctive therapy to diet to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. To reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments |
| 18 | 202968 | Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg | Watson Laboratories, Inc. | Vytorin (Ezetimibe and Simvastatin), 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg | 4/26/2017 | For use as adjunctive therapy to diet to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. To reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments |
| 17 | 200909 | Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg | Dr. Reddys Laboratories International SA | Vytorin (Ezetimibe and Simvastatin) Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg | 4/26/2017 | For use as adjunctive therapy to diet to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. To reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments |
| 16 | 206084 | Ezetimibe and Atorvastatin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg | Watson Laboratories, Inc. | Liptruzet (Ezetimibe and Atorvastatin) Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg | 4/26/2017 | For use to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia and to reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid lowering treatments |
| 15 | 204867 | Prednisone Delayed-Release Tablets, 1mg, 2mg, 5mg | Actavis Laboratories FL Inc | Rayos (Prednisone) Delayed-Release Tablets, 1mg, 2mg, 5mg | 4/25/2017 | For use as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation. For the treatment of certain endocrine conditions. For palliation of certain neoplastic conditions |
| 14 | 202294 | Dexlansoprazole Delayed-Release Capsules, 60 mg | Par Pharmaceutical Inc. | Dexilant (Dexlansoprazole Delayed-Release) Capsules, 60 mg | 4/19/2017 | For healing of all grades of erosive esophagitis, maintenance of healed EE and relief of heartburn, and treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD) |
| 13 | 208258 | Tazarotene Cream, 0.1% | Taro Pharmaceuticals USA, Inc. | Tazorac and Avage (Tazarotene) Cream, 0.1% | 4/3/2017 |
For use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs |
| 12 | 204726 | Silodosin Capsules, 4 mg, 8 mg | Sandoz Inc. | Rapaflo (Silodosin) Capsules, 4 mg, 8 mg | 3/31/2017 | For the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) |
| 11 | 205468 | Venlafaxine Hydrochloride Extended-release Tablets, 225 mg (base) | Nostrum Laboratories, Inc. | Venlafaxine Hydrochloride ER tablet (Venlafaxine Hydrochloride Extended-release Tablets, 225 mg (base)) | 3/24/2017 | For treatment of major depressive disorder and social anxiety disorder |
| 10 | 207809 | Melphalan Tablets USP, 2 mg | Alvogen Malta Operations Ltd. | Alkeran (Melphalan) Tablets, 2 mg | 3/22/2017 | For palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary |
| 9 | 204929 | Zileuton Extended-Release Tablets, 600 mg | Pack Pharmaceuticals, LLC | Zyflo CR (Zileuton) Extended-Release Tablets, 600 mg | 3/17/2017 | For the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older |
| 8 | 202511 | Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces | Lupin Inc. | Suprep Bowel Prep Kit (Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate) Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces | 2/23/2017 | For cleansing of the colon in preparation for colonscopy in adults |
| 7 | 207952 | Logilia Ulipristal Acetate, 30 mg | Teva Pharmaceuticals USA, Inc. | Ella (Ulipristal Acetate) Tablets, 30 mg | 2/13/2017 | For prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure |
| 6 | 206939 | Cefixime for Oral Suspension USP, 500 mg/5 mL | Belcher Pharmaceuticals, LLC | Suprax (Cefixime) for Oral Suspension, 500 mg/5 mL | 2/6/2017 | To reduce the development of drug-resistant bacteria and maintain the effectiveness for oral suspension |
| 5 | 208328 | Memantine and Donepezil Hydrochlorides Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mg | Amneal Pharmaceuticals LLC | Namzaric (Memantine and Donepezil Hydrochlorides) Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mg | 1/27/2017 | For the treatment of moderate to severe dementia of the Alzheimer’s type |
| 4 | 206836 | Dalfampridine Extended-Release Tablets, 10 mg | Actavis Laboratories FL, Inc. | Ampyra (Dalfampridine) Extended-Release Tablets, 10 mg | 1/23/2017 | To improve walking in patients with multiple sclerosis (MS) |
| 3 | 206811 | Dalfampridine Extended-Release Tablets, 10 mg | Aurobindo Pharma Limited | Ampyra (Dalfampridine) Extended-Release Tablets, 10 mg | 1/23/2017 | To improve walking in patients with multiple sclerosis (MS) |
| 2 | 202090 | Sodium Oxybate Oral Solution, 500 mg/mL | Roxane Laboratories, Inc. | Xyrem (Sodium Oxybate) Oral Solution, 500 mg/mL | 1/17/2017 | For the treatment of Cataplexy in narcolepsy; excessive daytime sleepiness (EDS) in narcolepsy |
| 1 | 207160 | Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mL | Aurobindo Pharma Limited | Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mL | 1/4/2017 | Antiepileptic drug indicated for adjunct therapy in adults (≥16 years of age) with certain seizure types when oral administration is temporarily not feasible |
Note: As outlined in the Proposed Criteria for First Generic Submissions for Purposes of ANDA, certain ANDAs are deemed “first generic” for the purposes of review prioritization. In this context, a first generic application is any received ANDA: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.
*This table reflects current data as of the date the listed approval was made. Post-approval status changes, including approved use or indications, approval date, approval status, etc. are not reflected here. To view the most current information on any ANDA listed, please check its Drugs@FDA listing.
+Due to space limitations, abbreviated indications are listed. For full indication information, please check Drugs@FDA.
To view all Generic Drug Approvals and Tentative Approvals, use the "Drug Approval Reports by Month" feature on Drugs@FDA and select "Original Abbreviated New Drug Approvals (ANDAs) by Month" for Generic Approvals or "Tentative Approvals by Month" for Tentative Approvals. The database is updated daily.