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Generated: November 18, 2018

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Details for New Drug Application (NDA): 072100

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NDA 072100 describes DESIPRAMINE HYDROCHLORIDE, which is a drug marketed by Actavis Totowa, Amneal Pharms Co, Ani Pharms Inc, Heritage Pharms Inc, Ingenus Pharms Llc, Sandoz, and Usl Pharma, and is included in twenty 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 072100
Tradename:DESIPRAMINE HYDROCHLORIDE
Applicant:Sandoz
Ingredient:desipramine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 072100
Medical Subject Heading (MeSH) Categories for 072100
Suppliers and Packaging for NDA: 072100
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESIPRAMINE HYDROCHLORIDE desipramine hydrochloride TABLET;ORAL 072100 ANDA Sandoz Inc 0781-1972 0781-1972-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-1972-01)
DESIPRAMINE HYDROCHLORIDE desipramine hydrochloride TABLET;ORAL 072100 ANDA Sandoz Inc 0781-1972 0781-1972-10 1000 TABLET, FILM COATED in 1 BOTTLE (0781-1972-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 24, 1988TE:ABRLD:No

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