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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 211822


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NDA 211822 describes CLOMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, 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-three 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-four suppliers are listed for this compound. Additional details are available on the clomipramine hydrochloride profile page.
Summary for 211822
Tradename:CLOMIPRAMINE HYDROCHLORIDE
Applicant:Alembic
Ingredient:clomipramine hydrochloride
Patents:0
Pharmacology for NDA: 211822
Medical Subject Heading (MeSH) Categories for 211822
Suppliers and Packaging for NDA: 211822
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride CAPSULE;ORAL 211822 ANDA Alembic Pharmaceuticals Limited 46708-407 46708-407-30 30 CAPSULE in 1 BOTTLE (46708-407-30)
CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride CAPSULE;ORAL 211822 ANDA Alembic Pharmaceuticals Limited 46708-407 46708-407-31 100 CAPSULE in 1 BOTTLE (46708-407-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Aug 4, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Aug 4, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Aug 4, 2021TE:ABRLD:No

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