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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216911

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NDA 216911 describes CHLORPROMAZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Genus, Pharm Assoc, Rubicon, Wockhardt, Abraxis Pharm, Aspiro, Deva Hlding, Dr Reddys, Eugia Pharma, Gland, Hikma, Marsam Pharms Llc, Thinq Pharm-cro Pvt, Watson Labs, Wyeth Ayerst, Zydus Pharms, Alpharma Us Pharms, Abbott, Alembic, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, 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-four NDAs. It is available from thirty-four 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. Thirty-four suppliers are listed for this compound. Additional details are available on the chlorpromazine hydrochloride profile page.

Summary for 216911

Tradename:	CHLORPROMAZINE HYDROCHLORIDE
Applicant:	Gland
Ingredient:	chlorpromazine hydrochloride
Patents:	0

Pharmacology for NDA: 216911

Suppliers and Packaging for NDA: 216911

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	INJECTABLE;INJECTION	216911	ANDA	Piramal Critical Care Inc.	66794-249	66794-249-42	25 VIAL in 1 CARTON (66794-249-42) / 1 mL in 1 VIAL
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	INJECTABLE;INJECTION	216911	ANDA	Piramal Critical Care Inc.	66794-250	66794-250-42	25 VIAL in 1 CARTON (66794-250-42) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Oct 4, 2024	TE:	AP	RLD:	No

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