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  6. Status of OTC Rulemakings
  7. Rulemaking History for OTC Cholecystokinetic Drug Products
  1. Status of OTC Rulemakings

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

 

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