Details for New Drug Application (NDA): 091292

NDA 091292 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Onesource Specialty, Roxane, Rubicon Research, Teva, Zydus Lifesciences, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Pai Holdings, Perrigo, Perrigo R And D, Watson Labs, Wockhardt Bio Ag, Able, Aurobindo Pharma, Contract Pharmacal, L Perrigo Co, LNK, Ohm Labs, Granules, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd, and is included in thirty-eight NDAs. It is available from ninety-eight suppliers. Additional details are available on the LOPERAMIDE HYDROCHLORIDE profile page.

The generic ingredient in LOPERAMIDE HYDROCHLORIDE 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 091292

Tradename:	LOPERAMIDE HYDROCHLORIDE
Applicant:	Perrigo R And D
Ingredient:	loperamide hydrochloride
Patents:	0

Pharmacology for NDA: 091292

Mechanism of Action

Opioid Agonists

Medical Subject Heading (MeSH) Categories for 091292

Antidiarrheals

Suppliers and Packaging for NDA: 091292

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	091292	ANDA	L. Perrigo Company	0113-1645	0113-1645-26	120 mL in 1 BOTTLE (0113-1645-26)
LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	091292	ANDA	L. Perrigo Company	0113-1645	0113-1645-34	240 mL in 1 BOTTLE (0113-1645-34)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION;ORAL			Strength	1MG/7.5ML
Approval Date:	May 20, 2011	TE:		RLD:	No

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