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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071918

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NDA 071918 describes DOXEPIN HYDROCHLORIDE, which is a drug marketed by Amneal Pharms Co, Dava Pharms Inc, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Watson Labs Teva, Pharm Assoc, Silarx, Teva Pharms, Wockhardt, and Actavis Elizabeth, and is included in fifty-six NDAs. It is available from twenty-six suppliers. Additional details are available on the DOXEPIN HYDROCHLORIDE profile page.

The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for 071918

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 071918

Medical Subject Heading (MeSH) Categories for 071918

Suppliers and Packaging for NDA: 071918

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CONCENTRATE;ORAL 071918 ANDA Morton Grove Pharmaceuticals, Inc. 60432-651 60432-651-04 118 mL in 1 BOTTLE, PLASTIC (60432-651-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrengthEQ 10MG BASE/ML
Approval Date:Jul 20, 1988TE:AARLD:No


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