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Generated: October 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085762

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NDA 085762 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, Upsher-smith Labs, Usl Pharma, Valeant Pharm Intl, and Watson Labs, and is included in twenty-two NDAs. It is available from twenty-five 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-nine suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.
Pharmacology for NDA: 085762
Suppliers and Packaging for NDA: 085762
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 085762 ANDA KAISER FOUNDATION HOSPITALS 0179-0276 0179-0276-01 100 TABLET in 1 BOTTLE (0179-0276-01)
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085762 ANDA KAISER FOUNDATION HOSPITALS 0179-0276 0179-0276-20 20 TABLET in 1 BOTTLE (0179-0276-20)

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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