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

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