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Generated: April 27, 2017

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Details for New Drug Application (NDA): 081049

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NDA 081049 describes IMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Sandoz, Leading Pharma Llc, Vangard, Watson Labs, Par Pharm, West Ward, Teva, Lupin Ltd, Sun Pharm Inds, Oxford Pharms, Novartis, Lederle, Usl Pharma, and Roxane, and is included in thirty-seven NDAs. It is available from twenty suppliers. Additional details are available on the IMIPRAMINE HYDROCHLORIDE profile page.

The generic ingredient in IMIPRAMINE HYDROCHLORIDE is imipramine hydrochloride. There are thirty-four drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.

Summary for NDA: 081049

Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 081049

Suppliers and Packaging for NDA: 081049

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
imipramine hydrochloride
TABLET;ORAL 081049 ANDA REMEDYREPACK INC. 49349-207 49349-207-02 30 TABLET, FILM COATED in 1 BLISTER PACK (49349-207-02)
imipramine hydrochloride
TABLET;ORAL 081049 ANDA A-S Medication Solutions LLC 50090-0035 50090-0035-0 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-0035-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jun 5, 1990TE:ABRLD:No

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