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Serving leading biopharmaceutical companies globally:

Accenture
Harvard Business School
Johnson and Johnson
Cipla
Healthtrust
Express Scripts
Deloitte
Fish and Richardson
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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086727

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NDA 086727 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 086727
Pharmacology for NDA: 086727
Suppliers and Packaging for NDA: 086727
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 086727 ANDA Stat Rx USA 16590-080 16590-080-30 30 TABLET in 1 BOTTLE (16590-080-30)
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 086727 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-594 43353-594-90 240 TABLET in 1 BOTTLE (43353-594-90)

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 leading biopharmaceutical companies globally:

AstraZeneca
Healthtrust
Express Scripts
Farmers Insurance
McKesson
Teva
Accenture
Argus Health
Cantor Fitzgerald

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