Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Imodium A-D (loperamide HCL) Liquid, McNeil Consumer, Package Change | Loperamide hydrochloride capsules, Banner Pharmacaps, Approval | Imodium (loperamide HCL) Capsule, McNeil Consumer, Labeling Revision | Loperamide Hydrochloride and Simethicone Tablets, Ranbaxy, Approval | Loperamide Hydrochloride/Simethicone Chewable Tablets, Perrigo Co., Facility Addition & Control Supplement | Loperamide Hydrochloride Capsules, Mylan Pharma, Labeling | Imodium Advance (loperamide HCl and simethicone) Tablets, McNeil Consumer, Formulation Revision | Imodium Advanced (loperamide HCl and simethicone) Tablets, McNeil Consumer Healthcare, Labeling Revision | Imodium Advanced (loperamide hydrochloride and simethicone) Chewable Tablets, McNeil Consumer, Efficacy Supplement with Clinical Data to Support | Imodium Advanced (loperamide hydrochloride and simethicone) Tablets, McNeil Consumer, Efficacy Supplement with Clinical Data to Support ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com