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Last Updated: April 16, 2024

Details for New Drug Application (NDA): 088276


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NDA 088276 describes IMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Novartis, Chartwell, Leading, Lederle, Oxford Pharms, Par Pharm, Roxane, Sandoz, Specgx Llc, Strides Pharma, Sun Pharm Industries, Teva, Usl Pharma, Vangard, Watson Labs, and West Ward, and is included in thirty-six NDAs. It is available from fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.
Summary for 088276
Tradename:IMIPRAMINE HYDROCHLORIDE
Applicant:Strides Pharma
Ingredient:imipramine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 088276
Suppliers and Packaging for NDA: 088276
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMIPRAMINE HYDROCHLORIDE imipramine hydrochloride TABLET;ORAL 088276 ANDA Golden State Medical Supply, Inc. 60429-097 60429-097-01 100 TABLET in 1 BOTTLE (60429-097-01)
IMIPRAMINE HYDROCHLORIDE imipramine hydrochloride TABLET;ORAL 088276 ANDA Strides Pharma Science Limited 64380-171 64380-171-01 100 TABLET in 1 BOTTLE, PLASTIC (64380-171-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Oct 21, 1983TE:ABRLD:No

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