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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 204963


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NDA 204963 describes DESIPRAMINE HYDROCHLORIDE, which is a drug marketed by Actavis Totowa, Alembic, Amneal Pharms Co, Ani Pharms, Chartwell Rx, Heritage Pharms, Novast Labs, and Usl Pharma, and is included in sixteen NDAs. It is available from nine suppliers. Additional details are available on the DESIPRAMINE HYDROCHLORIDE profile page.

The generic ingredient in DESIPRAMINE HYDROCHLORIDE is desipramine hydrochloride. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the desipramine hydrochloride profile page.
Summary for 204963
Tradename:DESIPRAMINE HYDROCHLORIDE
Applicant:Novast Labs
Ingredient:desipramine hydrochloride
Patents:0
Pharmacology for NDA: 204963
Medical Subject Heading (MeSH) Categories for 204963
Suppliers and Packaging for NDA: 204963
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESIPRAMINE HYDROCHLORIDE desipramine hydrochloride TABLET;ORAL 204963 ANDA Ingenus Pharmaceuticals, LLC 50742-112 50742-112-01 100 TABLET in 1 BOTTLE (50742-112-01)
DESIPRAMINE HYDROCHLORIDE desipramine hydrochloride TABLET;ORAL 204963 ANDA Ingenus Pharmaceuticals, LLC 50742-113 50742-113-01 100 TABLET in 1 BOTTLE (50742-113-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 26, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Dec 26, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 26, 2017TE:ABRLD:No

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