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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 Leg Muscle Cramp Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Leg Muscle Cramp Drug Products
  
  	
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    Print**Monograph**(21 CFR 310.546)**:***Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps*

FDA Archive-It webpage:
Rulemaking History for OTC Leg Muscle Cramp Drug ProductsSearch for Federal Register documents:

GPO Federal Register Database (1994 to present)
	HeinOnline provides online access to Federal Registers from 1936-forward

**Leg Muscle Cramp Drug Products**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			10/1/1982
			47FR43562Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			11/8/1985
			50FR46588Correction
			12/2/1985
			50FR49409Final Rule
			Date
			*FR* CitationFinal Monograph
			8/22/1994
			59FR43234Correction
			9/28/1994
			59FR49350Notice: Enforcement Action
			12/15/2006
			71FR75557

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