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Details for New Drug Application (NDA): 074694

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NDA 074694 describes CLOMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Watson Labs, Mylan, Teva, Sandoz, and Taro, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the CLOMIPRAMINE HYDROCHLORIDE profile page.

The generic ingredient in CLOMIPRAMINE HYDROCHLORIDE is clomipramine hydrochloride. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the clomipramine hydrochloride profile page.

Summary for NDA: 074694

Tradename:
CLOMIPRAMINE HYDROCHLORIDE
Applicant:
Taro
Ingredient:
clomipramine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 074694

Suppliers and Packaging for NDA: 074694

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOMIPRAMINE HYDROCHLORIDE
clomipramine hydrochloride
CAPSULE;ORAL 074694 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7591 0615-7591-39 30 CAPSULE in 1 BLISTER PACK (0615-7591-39)
CLOMIPRAMINE HYDROCHLORIDE
clomipramine hydrochloride
CAPSULE;ORAL 074694 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4011 51672-4011-1 100 CAPSULE in 1 BOTTLE (51672-4011-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Dec 31, 1996TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Dec 31, 1996TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Dec 31, 1996TE:ABRLD:No


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