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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking12/9/198045FR81154
Proposed RuleDateFR Citation
Proposed Rule: No GRASE ingredients & adds professional labeling for antacids1/15/198550FR2160
Final RuleDateFR Citation
Final Monograph: No GRASE ingredients & adds professional labeling for antacids5/11/199055FR19852


Page Last Updated: 06/26/2017
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