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U.S. Department of Health and Human Services


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Rulemaking History for OTC Cholecystokinetic Drug Products

Final Monograph (21 CFR part 357 subpart C):
Miscellaneous Internal Drug Products for Over-the-Counter Human Use: Cholecystokinetic Drug Products

OTC Cholecystokinetic Drug Products found on this page:

Cholecystokinetic Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 2/12/1980 45FR9286
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 8/24/1982 47FR37068
Final Rule Date FR Citation
Final Monograph [PDF] 6/10/1983 48FR27004

Cholecystokinetic Drug Products: Hydrogenated Soybean Oil
Proposed Rule Date FR Citation
Proposed Rule: Adds hydrogenated soybean oil as GRASE active ingredient [PDF] 8/15/1988 53FR30786
Final Rule Date FR Citation
Final Rule [PDF] 2/28/1989 54FR8321