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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for OTC Sweet Spirits of Nitre Drug Products

Final Monograph (21 CFR 310.502(a)):
Certain drugs accorded new drug status through rulemaking procedures 

OTC Sweet Spirits of Nitre Drug Products found on this page:


Sweet Spirits of Nitre Drug Products: Original Classification
Proposed Rule Date FR Citation
Proposed Rule: Classifies sweet spirits of nitre as nonmonograph [PDF] 2/22/1980 45FR11846
    Correction [PDF] 3/25/1980 45FR19265
Final Rule Date FR Citation
Final Rule [PDF] 6/27/1980 45FR43400
Sweet Spirits of Nitre Drug Products: Consolidation of Drug Regulations
Proposed Rule Date FR Citation
Proposed Rule: Removes 21 CFR 310.525 and adds 21 CFR 310.502 [PDF] 6/11/1996 61FR29502
Final Rule Date FR Citation
Final Rule [PDF] 3/14/1997 62FR12083
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