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Last Updated: October 7, 2022

Details for New Drug Application (NDA): 215483


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NDA 215483 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 215483
Tradename:DOXEPIN HYDROCHLORIDE
Applicant:Jubilant Cadista
Ingredient:doxepin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 215483
Medical Subject Heading (MeSH) Categories for 215483
Suppliers and Packaging for NDA: 215483
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 215483 ANDA Quality Care Products, LLC 55700-982 55700-982-30 30 CAPSULE in 1 BOTTLE, PLASTIC (55700-982-30)
DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 215483 ANDA JUBILANT CADISTA PHARMACEUTICALS INC. 59746-700 59746-700-01 100 CAPSULE in 1 BOTTLE, PLASTIC (59746-700-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Mar 14, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Mar 14, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Mar 14, 2022TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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Dow
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