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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 211603


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NDA 211603 describes DOXEPIN HYDROCHLORIDE, which is a drug marketed by Adaptis, Aiping Pharm Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Dava Pharms Inc, Endo Operations, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading, Mankind Pharma, Micro Labs, MSN, Mylan Pharms Inc, New River, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, Unique Pharm, Velzen Pharma Pvt, Watson Labs, Watson Labs Teva, Zydus Lifesciences, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Actavis Elizabeth, Rk Pharma, and Strides Pharma, and is included in seventy-seven NDAs. It is available from forty-eight 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. Fifty suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 211603
Tradename:DOXEPIN HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:doxepin hydrochloride
Patents:0
Pharmacology for NDA: 211603
Medical Subject Heading (MeSH) Categories for 211603
Suppliers and Packaging for NDA: 211603
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 211603 ANDA Medsource Pharmaceuticals 45865-103 45865-103-30 30 CAPSULE in 1 BOTTLE (45865-103-30)
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 211603 ANDA Aurobindo Pharma Limited 59651-173 59651-173-01 100 CAPSULE in 1 BOTTLE (59651-173-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Mar 27, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Mar 27, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Mar 27, 2019TE:ABRLD:No

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