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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213590

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NDA 213590 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 213590

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

Pharmacology for NDA: 213590

Suppliers and Packaging for NDA: 213590

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	213590	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-803	23155-803-01	100 TABLET, COATED in 1 BOTTLE (23155-803-01)
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	213590	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-804	23155-804-01	100 TABLET, COATED in 1 BOTTLE (23155-804-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Aug 31, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Aug 31, 2020	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Aug 31, 2020	TE:	AB	RLD:	No

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