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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 216724

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NDA 216724 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, MSN, Thinq Pharm-cro Pvt, Watson Labs, Wyeth Ayerst, Zydus Pharms, Alpharma Us Pharms, Abbott, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Cycle, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Kv Pharm, Lannett Co Inc, Lederle, Lupin, Purepac Pharm, Pvt Form, Somerset Theraps Llc, Sun Pharm, Teva Pharms, Upsher Smith Labs, Vangard, West Ward, Zameer Pharms, and Zydus Lifesciences, and is included in seventy-five NDAs. It is available from thirty-three 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 216724

Tradename:	CHLORPROMAZINE HYDROCHLORIDE
Applicant:	Thinq Pharm-cro Pvt
Ingredient:	chlorpromazine hydrochloride
Patents:	0

Pharmacology for NDA: 216724

Suppliers and Packaging for NDA: 216724

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	INJECTABLE;INJECTION	216724	ANDA	Fresenius Kabi USA, LLC	65219-128	65219-128-01	25 VIAL in 1 CARTON (65219-128-01) / 1 mL in 1 VIAL (65219-128-00)
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	INJECTABLE;INJECTION	216724	ANDA	Fresenius Kabi USA, LLC	65219-130	65219-130-02	25 VIAL in 1 CARTON (65219-130-02) / 2 mL in 1 VIAL (65219-130-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Dec 10, 2024	TE:	AP	RLD:	No

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