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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 216788

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NDA 216788 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 216788

Tradename:	CHLORPROMAZINE HYDROCHLORIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	chlorpromazine hydrochloride
Patents:	0

Pharmacology for NDA: 216788

Suppliers and Packaging for NDA: 216788

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	216788	ANDA	Aurobindo Pharma Limited	59651-567	59651-567-01	100 TABLET in 1 BOTTLE (59651-567-01)
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	216788	ANDA	Aurobindo Pharma Limited	59651-568	59651-568-01	100 TABLET in 1 BOTTLE (59651-568-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 25, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Apr 25, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Apr 25, 2025	TE:	AB	RLD:	No

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