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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 040903


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NDA 040903 describes IMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Novartis, Chartwell, Leading, Lederle, Oxford Pharms, Par Pharm, Roxane, Sandoz, Specgx Llc, Strides Pharma Intl, Sun Pharm Industries, Teva, Usl Pharma, Vangard, Watson Labs, and West Ward, and is included in thirty-six NDAs. It is available from twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.
Summary for 040903
Tradename:IMIPRAMINE HYDROCHLORIDE
Applicant:Leading
Ingredient:imipramine hydrochloride
Patents:0
Pharmacology for NDA: 040903
Suppliers and Packaging for NDA: 040903
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMIPRAMINE HYDROCHLORIDE imipramine hydrochloride TABLET;ORAL 040903 ANDA A-S Medication Solutions 50090-3148 50090-3148-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-3148-0)
IMIPRAMINE HYDROCHLORIDE imipramine hydrochloride TABLET;ORAL 040903 ANDA Coupler LLC 67046-1564 67046-1564-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1564-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 24, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Oct 24, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Oct 24, 2012TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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