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Generated: April 25, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074721

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NDA 074721 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, Lannett Co Inc, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, and Actavis Elizabeth, and is included in fifty-six NDAs. It is available from twenty-five 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 074721
Applicant:Lannett Co Inc
Ingredient:doxepin hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 074721
Medical Subject Heading (MeSH) Categories for 074721
Suppliers and Packaging for NDA: 074721
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CONCENTRATE;ORAL 074721 ANDA Lannett Company, Inc. 54838-512 54838-512-40 120 mL in 1 BOTTLE, PLASTIC (54838-512-40)
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CONCENTRATE;ORAL 074721 ANDA Carilion Materials Management 68151-5656 68151-5656-7 1 mL in 1 BOTTLE (68151-5656-7)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrengthEQ 10MG BASE/ML
Approval Date:Dec 29, 1998TE:AARLD:No

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