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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216678

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NDA 216678 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 216678

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

Pharmacology for NDA: 216678

Suppliers and Packaging for NDA: 216678

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	CONCENTRATE;ORAL	216678	ANDA	Advagen Pharma Ltd	72888-457	72888-457-01	120 mL in 1 BOTTLE (72888-457-01)
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	CONCENTRATE;ORAL	216678	ANDA	Advagen Pharma Ltd	72888-458	72888-458-01	240 mL in 1 BOTTLE (72888-458-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CONCENTRATE;ORAL			Strength	30MG/ML
Approval Date:	Oct 10, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CONCENTRATE;ORAL			Strength	100MG/ML
Approval Date:	Oct 10, 2025	TE:	AB	RLD:	No

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