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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 Antiflatulent Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Antiflatulent Drug Products
  
  	
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    Print**Final Monograph**(21 CFR part 332)**:***Antiflatulent Products for Over-the-Counter Human Use*

OTC Antiflatulent Drug Products found on this page:

Original Active Ingredients and Labeling
	Statement of Identity and Indications
	Warnings**Antiflatulent Drug Products: Original Active Ingredients and Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking [PDF]
			4/5/1973
			38FR8714Correction [PDF]
			5/29/1973
			38FR14111Proposed Rule
			Date
			*FR* CitationTentative Final Monograph [PDF]
			11/12/1973
			38FR31260Correction [PDF]
			12/7/1973
			38FR33774Final Rule
			Date
			*FR* CitationFinal Monograph [PDF]
			6/4/1974
			39FR19862Technical Amendment: Revises indications [PDF]
			3/13/1975
			40FR11718Technical Amendment: Extends effective date [PDF]
			5/23/1975
			40FR22542

**Antiflatulent Drug Products: Statement of Identity and Indications**

Proposed Rule
			Date
			*FR* CitationProposed Rule [PDF]
			1/29/1988
			53FR2716Correction [PDF]
			3/3/1988
			53FR6916Extension of Comment Period [PDF]
			4/19/1988
			53FR12778Final Rule
			Date
			*FR* CitationFinal Rule [PDF]
			3/5/1996
			61FR8836

**Antiflatulent Drug Products: Warnings**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Exempts from "accidental overdose" warning [PDF]
			4/13/1984
			49FR14908Correction [PDF]
			5/21/1984
			49FR21350Final Rule
			Date
			*FR* CitationFinal Rule [PDF]
			8/1/1986
			51FR27762Correction [PDF]
			9/10/1986
			51FR32212

                                                                                  Content current as of:
      03/01/2022Historical Status of OTC Rulemakings
 
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