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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 084114

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NDA 084114 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 084114

Tradename:	CHLORPROMAZINE HYDROCHLORIDE
Applicant:	Upsher Smith Labs
Ingredient:	chlorpromazine hydrochloride
Patents:	0

Pharmacology for NDA: 084114

Suppliers and Packaging for NDA: 084114

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	084114	ANDA	Upsher-Smith Laboratories, LLC	0832-6020	0832-6020-00	100 TABLET, FILM COATED in 1 BOTTLE (0832-6020-00)
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	084114	ANDA	Upsher-Smith Laboratories, LLC	0832-6020	0832-6020-01	1 BLISTER PACK in 1 CARTON (0832-6020-01) / 100 TABLET, FILM COATED in 1 BLISTER PACK (0832-6020-89)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

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