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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 214541


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NDA 214541 describes LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, which is a drug marketed by Perrigo, Aurobindo Pharma Ltd, Bionpharma, Granules, Guardian Drug, Hetero Labs Ltd V, Perrigo R And D, and Sun Pharm Inds Ltd, and is included in eight NDAs. It is available from thirty-four suppliers. Additional details are available on the LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE profile page.

The generic ingredient in LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 214541
Tradename:LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Applicant:Guardian Drug
Ingredient:loperamide hydrochloride; simethicone
Patents:0
Pharmacology for NDA: 214541
Mechanism of ActionOpioid Agonists
Physiological EffectSkin Barrier Activity
Suppliers and Packaging for NDA: 214541
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 214541 ANDA Guardian Drug Company 53041-263 53041-263-50 1 BLISTER PACK in 1 CARTON (53041-263-50) / 6 TABLET in 1 BLISTER PACK
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 214541 ANDA Discount Drug Mart, Inc 53943-263 53943-263-33 4 BLISTER PACK in 1 CARTON (53943-263-33) / 6 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength2MG;125MG
Approval Date:May 27, 2021TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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