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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 214542


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NDA 214542 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the chlorpromazine hydrochloride profile page.
Summary for 214542
Tradename:CHLORPROMAZINE HYDROCHLORIDE
Applicant:Genus
Ingredient:chlorpromazine hydrochloride
Patents:0
Pharmacology for NDA: 214542
Suppliers and Packaging for NDA: 214542
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride CONCENTRATE;ORAL 214542 ANDA Sandoz, Inc. 0781-4027 0781-4027-53 120 mL in 1 BOTTLE, PLASTIC (0781-4027-53)
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride CONCENTRATE;ORAL 214542 ANDA Sandoz, Inc. 0781-4028 0781-4028-22 240 mL in 1 BOTTLE, PLASTIC (0781-4028-22)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength30MG/ML
Approval Date:Jun 2, 2021TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength100MG/ML
Approval Date:Jun 2, 2021TE:RLD:No

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