Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Imodium Advanced (Loperamide HCl and Simethicone) Caplet McNeil Consumer Healthcare NDA 21-140 11/29/00 12/12/01 12/12/01 12/12/01 Imodium A-D Caplets McNeil Consumer Healthcare NDA 19860/S-018 Loperamide Hydrochloride & Simethicone Chewable Tablets, 2 mg/125 mg, OTC L. Perrigo Company ANDA 76-029 8/30/02 Loperamide Hydrochloride Tablets USP, 2 mg LNK International ANDA 76-497 6/10/03 Loperamide Hydrochloride Tablets USP, 2 mg L. Perrigo Company ANDA 75-232 LOPERAMIDE HYDROCHLORIDE Capsule; 2MG LOPERAMIDE HCL Geneva 017694 LOPERAMIDE HYDROCHLORIDE Capsule; 2MG IMODIUM MCNEIL CONS SPECLT 072741 LOPERAMIDE HYDROCHLORIDE Capsule; 2MG LOPERAMIDE HCL Mylan 073122 LOPERAMIDE HYDROCHLORIDE Capsule; 2MG LOPERAMIDE HCL Teva 073192 LOPERAMIDE HYDROCHLORIDE Capsule; 2MG LOPERAMIDE HCL Teva Imodium (loperamide HCL/simethicone) Caplets, McNeil Consumer Imodium A-D (loperamide HCL) Liquid, McNeil Consumer Imodium Advanced (loperamide HCL/simethicone) Caplets, McNeil Consumer Imodium Advanced (loperamide HCL/simethicone) Chewable Tablets, McNeil Consumer Imodium A-D (loperamide HCL) Liquid, McNeil Consumer, Formulation Revision   For the latest approval information, locate this drug using this index.