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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 212996


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NDA 212996 describes CHLORPROMAZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Genus, Pharm Assoc, Wockhardt, Abraxis Pharm, Deva Hlding, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hikma, Marsam Pharms Llc, Watson Labs, Wyeth Ayerst, Zydus Pharms, Alpharma Us Pharms, Abbott, Alembic, Amneal Pharms Co, Appco, Chartwell Rx, Cycle, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Kv Pharm, Lannett Co Inc, Lederle, Lupin, MSN, Purepac Pharm, Pvt Form, Sun Pharm, Teva Pharms, Upsher Smith Labs, Vangard, West Ward, and Zydus Lifesciences, and is included in seventy NDAs. It is available from twenty-nine suppliers. Additional details are available on the CHLORPROMAZINE HYDROCHLORIDE profile page.

The generic ingredient in CHLORPROMAZINE HYDROCHLORIDE is chlorpromazine hydrochloride. There are twenty-four drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the chlorpromazine hydrochloride profile page.
Summary for 212996
Pharmacology for NDA: 212996
Suppliers and Packaging for NDA: 212996
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride TABLET;ORAL 212996 ANDA Lannett Company, Inc. 0527-2961 0527-2961-37 100 TABLET, COATED in 1 BOTTLE (0527-2961-37)
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride TABLET;ORAL 212996 ANDA Lannett Company, Inc. 0527-2962 0527-2962-37 100 TABLET, COATED in 1 BOTTLE (0527-2962-37)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 22, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jan 22, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 22, 2021TE:ABRLD:No

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