Details for New Drug Application (NDA): 214541

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 twenty-nine 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 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 Action	Opioid Agonists
Physiological Effect	Skin 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	Wal-Mart Stores, Inc.	79903-116	79903-116-33	4 BLISTER PACK in 1 CARTON (79903-116-33) / 6 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	2MG;125MG
Approval Date:	May 27, 2021	TE:		RLD:	No

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