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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 212630

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NDA 212630 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 212630

Tradename:	CHLORPROMAZINE HYDROCHLORIDE
Applicant:	Chartwell Rx
Ingredient:	chlorpromazine hydrochloride
Patents:	0

Pharmacology for NDA: 212630

Suppliers and Packaging for NDA: 212630

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	212630	ANDA	Chartwell RX, LLC	62135-420	62135-420-90	90 TABLET, SUGAR COATED in 1 BOTTLE (62135-420-90)
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	212630	ANDA	Chartwell RX, LLC	62135-421	62135-421-90	90 TABLET, SUGAR COATED in 1 BOTTLE (62135-421-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 29, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Nov 29, 2021	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Nov 29, 2021	TE:	AB	RLD:	No

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