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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087708

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NDA 087708 describes DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, which is a drug marketed by West-ward Pharms Int, Able, Ani Pharms Inc, Ascot, Heather, Hikma Pharms, Inwood Labs, Kv Pharm, Lannett, Lederle, Mylan, Par Pharm, Parke Davis, Pvt Form, R And S Pharma, Roxane, Sandoz, Sun Pharm Industries, Usl Pharma, Valeant Pharm Intl, and Watson Labs, and is included in twenty-one NDAs. It is available from twenty-seven 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-two drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.

Summary for 087708

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 087708

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 West-Ward Pharmaceuticals Corp. 0054-3194 0054-3194-46 1 BOTTLE, DROPPER in 1 CARTON (0054-3194-46) > 60 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength0.025MG/5ML;2.5MG/5ML
Approval Date:May 3, 1982TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Teva
Cipla
Healthtrust
Novartis
Covington
Colorcon
Argus Health
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Accenture

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