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 In this section:

                Historical Status of OTC Rulemakings

Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription Drugs
          Historical Status of OTC Rulemakings
          Rulemaking History for OTC Antiemetic Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Antiemetic Drug Products
  
  	
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    Print**Final Monograph**(21 CFR part 336)**:***Antiemetic Drug Products for Over-the-Counter Human Use*

OTC Antiemetic Drug Products found on this page:

Original Active Ingredients and Labeling
	Warnings Related to Age
	Diphenhydramine Warnings**Antiemetic Drug Products: Original Active Ingredients and Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking [PDF]
			3/21/1975
			40FR12902Proposed Rule
			Date
			*FR* CitationTentative Final Monograph [PDF]
			7/13/1979
			44FR41064Reopening of Administrative Record: Category II and III active ingredients [PDF]
			10/26/1979
			44FR61610Final Rule
			Date
			*FR* CitationFinal Monograph [PDF]
			4/30/1987
			52FR15886Technical Amendment: Clarifies age range for children's dosage [PDF]
			9/15/1988
			53FR35808

**Antiemetic Drug Products: Warnings Related to Age**

Proposed Rule
			Date
			*FR* CitationProposed Rule [PDF]
			8/26/1993
			58FR45216Final Rule
			Date
			*FR* CitationFinal Rule [PDF]
			4/11/1994
			59FR16981

**Antiemetic Drug Products: Diphenhydramine Warnings**

Proposed Rule
			Date
			*FR* CitationProposed Rule [PDF]
			8/29/1997
			62FR45767Final Rule
			Date
			*FR* CitationFinal Rule [PDF]
			12/6/2002
			67FR72555

                                                                                  Content current as of:
      04/13/2017Historical Status of OTC Rulemakings
 
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