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Generated: August 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210819

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NDA 210819 describes DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, which is a drug marketed by West-ward Pharms Int, Able, Ani Pharms Inc, Ascot, Bayshore Pharms Llc, 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-three 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-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.
Pharmacology for NDA: 210819
Suppliers and Packaging for NDA: 210819
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 210819 ANDA Bayshore Pharmaceuticals, LLC 76385-107 76385-107-01 100 TABLET in 1 BOTTLE (76385-107-01)
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 210819 ANDA Bayshore Pharmaceuticals, LLC 76385-107 76385-107-10 1000 TABLET in 1 BOTTLE (76385-107-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.025MG;2.5MG
Approval Date:Nov 13, 2018TE:AARLD:No

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