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Details for New Drug Application (NDA): 090441

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NDA 090441 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 nineteen 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 suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.

Summary for NDA: 090441

Tradename:
IMIPRAMINE HYDROCHLORIDE
Applicant:
Lupin Ltd
Ingredient:
imipramine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 090441

Suppliers and Packaging for NDA: 090441

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMIPRAMINE HYDROCHLORIDE
imipramine hydrochloride
TABLET;ORAL 090441 ANDA REMEDYREPACK INC. 52125-572 52125-572-02 30 TABLET, FILM COATED in 1 BLISTER PACK (52125-572-02)
IMIPRAMINE HYDROCHLORIDE
imipramine hydrochloride
TABLET;ORAL 090441 ANDA Physicians Total Care, Inc. 54868-2221 54868-2221-3 30 TABLET, FILM COATED in 1 BOTTLE (54868-2221-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 11, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 11, 2010TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Mar 11, 2010TE:ABRLD:No


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