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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074947

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NDA 074947 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 twelve suppliers. Additional details are available on the CLOMIPRAMINE HYDROCHLORIDE profile page.

The generic ingredient in CLOMIPRAMINE HYDROCHLORIDE is clomipramine hydrochloride. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the clomipramine hydrochloride profile page.
Summary for 074947
Ingredient:clomipramine hydrochloride
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 074947
Medical Subject Heading (MeSH) Categories for 074947
Suppliers and Packaging for NDA: 074947
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride CAPSULE;ORAL 074947 ANDA Mylan Pharmaceuticals Inc. 0378-3025 N 0378-3025-01
CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride CAPSULE;ORAL 074947 ANDA Mylan Pharmaceuticals Inc. 0378-3050 N 0378-3050-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Apr 30, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Apr 30, 1998TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Apr 30, 1998TE:ABRLD:No

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