Details for New Drug Application (NDA): 087708

NDA 087708 describes DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, which is a drug marketed by Hikma, Able, Ani Pharms, Ascot, Bayshore Pharms Llc, Chartwell Rx, Dr Reddys Labs Sa, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading, Lederle, Mylan, Parke Davis, Pvt Form, R And S Pharma, Roxane, Specgx Llc, Strides Pharma, Sun Pharm Industries, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, and Winder Labs Llc, and is included in twenty-eight NDAs. It is available from nineteen suppliers. Additional details are available on the DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE profile page.

The generic ingredient in DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE is atropine sulfate; diphenoxylate hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.

Summary for 087708

Tradename:	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Applicant:	Hikma
Ingredient:	atropine sulfate; diphenoxylate hydrochloride
Patents:	0

Pharmacology for NDA: 087708

Mechanism of Action

Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 087708

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	SOLUTION;ORAL	087708	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3194	0054-3194-46	1 BOTTLE in 1 CARTON (0054-3194-46) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	0.025MG/5ML;2.5MG/5ML
Approval Date:	May 3, 1982	TE:		RLD:	No

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