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 thirty 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-one 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	Procaps S.A. de C.V.	76864-100	76864-100-12	12 BLISTER PACK in 1 CARTON (76864-100-12) / 1 CAPSULE 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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