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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040357

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NDA 040357 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-eight 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-two suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.
Summary for 040357
Tradename:DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Applicant:Par Pharm
Ingredient:atropine sulfate; diphenoxylate hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040357
Suppliers and Packaging for NDA: 040357
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 040357 ANDA Bryant Ranch Prepack 63629-1734 63629-1734-2 30 TABLET in 1 BOTTLE (63629-1734-2)
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 040357 ANDA Bryant Ranch Prepack 63629-1734 63629-1734-4 10 TABLET in 1 BOTTLE (63629-1734-4)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.025MG;2.5MG
Approval Date:May 2, 2000TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Cerilliant
Cantor Fitzgerald
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Daiichi Sankyo
Chubb
Queensland Health
Fish and Richardson
Moodys
Merck

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