U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Abbreviated New Drug Application (ANDA)
  7. Activities Report of the Generic Drugs Program (FY 2021) Monthly Performance
  1. Abbreviated New Drug Application (ANDA)

Activities Report of the Generic Drugs Program (FY 2021) Monthly Performance

GDUFA YEAR/
Actions This Month		 20-Oct 20-Nov 20-Dec 21-Jan 21-Feb 21-Mar 21-Apr 21-May 21-Jun 21-Jul 21-Aug 21-Sep FY-2021
Refuse to Receive (RTR) - Originals 3 6 0 1 7 4 3 11 3 4 3 1 46
Standard - GDUFA II 2 5 0 0 7 2 3 8 1 4 3 1 36
Priority - GDUFA II 1 1 0 1 0 2 0 3 2 0 0 0 10
GDUFA I 0 0 0 0 0 0 0 0 0 0 0 0 0
Acknowledgement - Original 52 47 31 57 88 61 70 85 59 53 58 75 736
Refuse to Receive (RTR) - PAS 0 0 0 0 0 0 1 0 0 0 0 0 1
Withdrawals  (all original ANDAs) 7 36 9 23 36 9 17 7 18 49 105 9 325
Approved ANDA 2 21 0 12 24 0 7 0 12 35 100 1 214
Unapproved ANDA 5 15 9 11 12 9 10 7 6 14 5 8 111
Withdrawals  (PAS) 5 5 5 3 9 0 5 5 6 4 4 4 55
Approvals  78 55 63 62 72 63 55 46 45 46 55 39 679
First Time Generics 9 3 7 5 16 8 11 5 9 3 11 6 93
 Not First Time Generics 69 52 56 57 56 55 44 41 36 43 44 33 586
First Cycle Approvals 19 7 10 17 9 17 8 7 4 10 10 3 121
Not First Cycle Approvals 59 48 53 45 63 46 47 39 41 36 45 36 558
Tentative Approvals  15 21 22 8 7 11 17 12 17 9 8 10 157
First Cycle Tentative Approvals (included above) 3 4 2 1 0 2 2 3 0 2 0 0 19
Complete Responses (CR) 167 171 154 157 183 140 149 127 125 169 157 152 1851
Information Requests (IR) 359 334 370 307 416 409 383 357 352 343 353 330 4313
Originals 215 184 203 177 236 258 220 216 188 188 200 195 2480
Supplements 144 150 167 130 180 151 163 141 164 155 153 135 1833
Discipline Review Letters (DRL) 199 166 168 131 158 204 159 163 253 181  184 264 2230
Drug Master File Completeness Assessment (DMF CA) 52 73 59 58 43 43 23 27 36 44 55 41 554

 

GDUFA YEAR (Receipts)
Submissions This Month		 20-Oct 20-Nov 20-Dec 21-Jan 21-Feb 21-Mar 21-Apr 21-May 21-Jun 21-Jul 21-Aug 21-Sep FY-2021
Abbreviated New Drug Applications (ANDA) + 20 40 124 36 50 131 60 41 76 45 65 121 809
Amendments 176 204 292 179 191 235 217 171 226 233 221 191 2536
Major 77 88 152 91 83 103 99 84 107 107 104 99 1194
Minor 51 81 79 45 55 71 53 47 63 62 60 50 717
Unsolicited Amendments ++ 48 35 61 43 53 61 65 40 56 64 57 42 625
Pre-Submission Facility Correspondence 12 3 3 6 3 2 3 1 5 5 1 3 47
CBE Supplements  958 961 787 611 562 844 832 1018 795 680 671 838 9557
PAS Supplements +++ 126 112 122 83 101 120 124 101 128 104 105 125 1351
DMFs - Type II 34 63 90 25 46 93 50 45 71 49 54 66 686
GDUFA YEAR (Receipts) 20-Oct 20-Nov 20-Dec 21-Jan 21-Feb 21-Mar 21-Apr 21-May 21-Jun 21-Jul 21-Aug 21-Sep FY-2021
Controls ++++ 314 307 281 331 372 404 292 268 319 349 371 289 3897
Requests for Clarfication 3 2 3 1 1 7 3 2 2 1 2 3 30
Post CR Meeting Requests This Month 8 5 2 3 7 8 5 8 11 4 5 2 68

 

NOTE: Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems, including application status updates.
These numbers are not intended for Congressional reporting purposes.

* = This data requires additional verification and will be posted when available.
+ = Original Receipts are reported as raw receipts (versus filed receipts).
++ = Due to system capabilities, counts for unsolicited amendments were previously based on amendments submitted after a tentative approval was issued. Starting in Oct. 2019 (FY 2020) the monthly metric report now captures all unsolicited amendments submitted to the agency.
+++ = PAS Supplements do not include REMS PAS supplements.
++++ = Controls count only those requests deemed appropriate for a control. FY 2021 controls were updated at FY 2021 closeout to accurately reflect monthly requests after migration to a new tracking system.

Previous Activities Reports

 

 

 

Back to Top