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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 088292


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NDA 088292 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 eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.
Summary for 088292
Tradename:IMIPRAMINE HYDROCHLORIDE
Applicant:Strides Pharma
Ingredient:imipramine hydrochloride
Patents:0
Pharmacology for NDA: 088292
Suppliers and Packaging for NDA: 088292
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMIPRAMINE HYDROCHLORIDE imipramine hydrochloride TABLET;ORAL 088292 ANDA Strides Pharma Science Limited 64380-169 64380-169-01 100 TABLET in 1 BOTTLE, PLASTIC (64380-169-01)
IMIPRAMINE HYDROCHLORIDE imipramine hydrochloride TABLET;ORAL 088292 ANDA Strides Pharma Science Limited 64380-169 64380-169-02 1000 TABLET in 1 BOTTLE, PLASTIC (64380-169-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 21, 1983TE:ABRLD:No

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