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Serving leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice
US Army

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085372

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NDA 085372 describes DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, which is a drug marketed by West-ward Pharms Int, Able, Ani Pharms Inc, Ascot, Fosun Pharma, Heather, Hikma Pharms, Inwood Labs, Kv Pharm, Lannett, Lederle, Mylan, Par Pharm, Parke Davis, Pvt Form, R And S Pharma, Roxane, Sun Pharm Industries, Usl Pharma, Valeant Pharm Intl, and Watson Labs, and is included in twenty-one NDAs. It is available from twenty-six 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. Thirty suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.
Summary for 085372
Ingredient:atropine sulfate; diphenoxylate hydrochloride
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 085372
Suppliers and Packaging for NDA: 085372
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085372 ANDA Lannett Company, Inc. 0527-1170 N 0527-1170-05
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085372 ANDA Lannett Company, Inc. 0527-1170 N 0527-1170-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.025MG;2.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
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