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Details for New Drug Application (NDA): 071588

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NDA 071588 describes DESIPRAMINE HYDROCHLORIDE, which is a drug marketed by Sandoz, Actavis Totowa, Ani Pharms Inc, Amneal Pharms Co, Heritage Pharms Inc, Corepharma, and Usl Pharma, and is included in nineteen NDAs. It is available from twelve 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. Fifteen suppliers are listed for this compound. Additional details are available on the desipramine hydrochloride profile page.

Summary for NDA: 071588

Tradename:
DESIPRAMINE HYDROCHLORIDE
Applicant:
Actavis Totowa
Ingredient:
desipramine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 071588

Suppliers and Packaging for NDA: 071588

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESIPRAMINE HYDROCHLORIDE
desipramine hydrochloride
TABLET;ORAL 071588 ANDA Actavis Pharma, Inc. 45963-343 45963-343-02 100 TABLET, FILM COATED in 1 BOTTLE (45963-343-02)
DESIPRAMINE HYDROCHLORIDE
desipramine hydrochloride
TABLET;ORAL 071588 ANDA Bryant Ranch Prepack 63629-5027 63629-5027-1 90 TABLET, FILM COATED in 1 BOTTLE (63629-5027-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jun 5, 1987TE:ABRLD:No


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