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Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074953

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NDA 074953 describes CLOMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Mylan, Sandoz, Taro, Teva, Watson Labs, and Zydus Pharms Usa Inc, and is included in nine NDAs. It is available from fourteen suppliers. Additional details are available on the CLOMIPRAMINE HYDROCHLORIDE profile page.

The generic ingredient in CLOMIPRAMINE HYDROCHLORIDE is clomipramine hydrochloride. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the clomipramine hydrochloride profile page.
Summary for 074953
Tradename:CLOMIPRAMINE HYDROCHLORIDE
Applicant:Sandoz
Ingredient:clomipramine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 074953
Medical Subject Heading (MeSH) Categories for 074953
Suppliers and Packaging for NDA: 074953
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride CAPSULE;ORAL 074953 ANDA Upsher-Smith Laboratories, Inc. 0832-0630 N 0832-0630-11
CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride CAPSULE;ORAL 074953 ANDA Upsher-Smith Laboratories, Inc. 0832-0631 N 0832-0631-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Jun 25, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jun 25, 1997TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Jun 25, 1997TE:ABRLD:No

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