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  7. Rulemaking History for OTC Antiemetic Drug Products
  1. Status of OTC Rulemakings

Rulemaking History for OTC Antiemetic Drug Products

Final Monograph (21 CFR part 336):
Antiemetic Drug Products for Over-the-Counter Human Use
 

OTC Antiemetic Drug Products found on this page:

Antiemetic Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]3/21/197540FR12902
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]7/13/197944FR41064
Reopening of Administrative Record: Category II and III active ingredients [PDF]10/26/197944FR61610
Final RuleDateFR Citation
Final Monograph [PDF]4/30/198752FR15886

    Technical Amendment: Clarifies age range for children's dosage [PDF]

9/15/198853FR35808

Antiemetic Drug Products: Warnings Related to Age

Proposed RuleDateFR Citation
Proposed Rule [PDF]8/26/199358FR45216
Final RuleDateFR Citation
Final Rule [PDF]4/11/199459FR16981

Antiemetic Drug Products: Diphenhydramine Warnings

Proposed RuleDateFR Citation
Proposed Rule [PDF]8/29/199762FR45767
Final RuleDateFR Citation
Final Rule [PDF]12/6/200267FR72555