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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Hypophosphatemia/Hyperphosphatemia Drug Products
  1. Historical Status of OTC Rulemakings

Rulemaking History for OTC Hypophosphatemia/Hyperphosphatemia Drug Products

Final Monographs (21 CFR 310.541 & 310.542):
Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphosphatemia/hyperphosphosphatemia

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Hypophosphatemia/Hyperphosphatemia Drug Products

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 12/9/1980 45FR81154
    Correction 1/9/1981 46FR2365
Proposed Rule Date FR Citation
Proposed Rule: No GRASE ingredients & adds professional labeling for antacids 1/15/1985 50FR2160
Final Rule Date FR Citation
Final Monograph: No GRASE ingredients & adds professional labeling for antacids 5/11/1990 55FR19852

 

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