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Last Updated: October 7, 2022

Details for New Drug Application (NDA): 212997


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NDA 212997 describes DOXEPIN HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Contract Pharmacal, Dava Pharms Inc, Edenbridge Pharms, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading Pharma Llc, Mankind Pharma, MSN, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro Pharm Inds Ltd, Watson Labs, Watson Labs Teva, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, Actavis Elizabeth, Rk Pharma, and Strides Pharma, and is included in sixty-seven NDAs. It is available from thirty-four 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-six suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Summary for 212997
Tradename:DOXEPIN HYDROCHLORIDE
Applicant:Lannett Co Inc
Ingredient:doxepin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212997
Medical Subject Heading (MeSH) Categories for 212997
Suppliers and Packaging for NDA: 212997
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 212997 ANDA Lannett Company, Inc. 0527-4062 0527-4062-37 100 CAPSULE in 1 BOTTLE (0527-4062-37)
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 212997 ANDA Lannett Company, Inc. 0527-4062 0527-4062-43 1000 CAPSULE in 1 BOTTLE (0527-4062-43)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Jul 24, 2020TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Jul 24, 2020TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Jul 24, 2020TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Medtronic
Express Scripts
Baxter
Johnson and Johnson

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