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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 074953


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NDA 074953 describes CLOMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma, Chemistry Hlth, Jubilant Cadista, Lupin Ltd, Mankind Pharma, Micro Labs, Mylan, Rk Pharma, Sandoz, Taro, Teva, Tulex Pharms Inc, Unique, Watson Labs, and Zydus Pharms, and is included in twenty-one NDAs. It is available from twenty-five suppliers. Additional details are available on the CLOMIPRAMINE HYDROCHLORIDE profile page.

The generic ingredient in CLOMIPRAMINE HYDROCHLORIDE is clomipramine hydrochloride. There are eleven drug master file entries for this compound. Twenty-six 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
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, LLC 0832-0630 0832-0630-11 100 CAPSULE in 1 BOTTLE (0832-0630-11)
CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride CAPSULE;ORAL 074953 ANDA Upsher-Smith Laboratories, LLC 0832-0631 0832-0631-11 100 CAPSULE in 1 BOTTLE (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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