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

OTC Antiemetic Drug Products found on this page:

Note: This page links to PDF files which require the free Adobe Acrobat Reader.


Antiemetic Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 3/21/1975 40FR12902
Proposed Rule Date FR Citation
Tentative Final Monograph 7/13/1979 44FR41064
Reopening of Administrative Record: Category II and III active ingredients 10/26/1979 44FR61610
Final Rule Date FR Citation
Final Monograph 8/1/1986 51FR27756
Correction: Final Monograph 4/30/1987 52FR15886

    Technical Amendment: Clarifies age range for children's dosage

9/15/1988 53FR35808

Antiemetic Drug Products: Warnings Related to Age
Proposed Rule Date FR Citation
Proposed Rule 8/26/1993 58FR45216
Final Rule Date FR Citation
Final Rule 4/11/1994 59FR16981

Antiemetic Drug Products: Diphenhydramine Warnings
Proposed Rule Date FR Citation
Proposed Rule 8/29/1997 62FR45767
Final Rule Date FR Citation
Final Rule 12/6/2002 67FR72555

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Date created: December 28, 2006; Last updated: June 13, 2008
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