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Last Updated: December 25, 2024

Details for New Drug Application (NDA): 218229

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NDA 218229 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 218229

Tradename:	CHLORPROMAZINE HYDROCHLORIDE
Applicant:	Deva Hlding
Ingredient:	chlorpromazine hydrochloride
Patents:	0

Pharmacology for NDA: 218229

Suppliers and Packaging for NDA: 218229

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	INJECTABLE;INJECTION	218229	ANDA	Devatis, Inc.	73043-048	73043-048-25	25 AMPULE in 1 CARTON (73043-048-25) / 1 mL in 1 AMPULE (73043-048-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Sep 24, 2024	TE:	AP	RLD:	No

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