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Last Updated: December 25, 2024

Details for New Drug Application (NDA): 080365

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NDA 080365 describes CHLORPROMAZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Genus, Pharm Assoc, Wockhardt, Abraxis Pharm, Deva Hlding, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hikma, Marsam Pharms Llc, Watson Labs, Wyeth Ayerst, Zydus Pharms, Alpharma Us Pharms, Abbott, Alembic, Amneal Pharms Co, Appco, 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 NDAs. It is available from twenty-nine 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the chlorpromazine hydrochloride profile page.

Summary for 080365

Tradename:	CHLORPROMAZINE HYDROCHLORIDE
Applicant:	Dr Reddys
Ingredient:	chlorpromazine hydrochloride
Patents:	0

Pharmacology for NDA: 080365

Suppliers and Packaging for NDA: 080365

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	INJECTABLE;INJECTION	080365	ANDA	Dr. Reddy's Laboratories Inc.,	43598-140	43598-140-25	25 VIAL in 1 CARTON (43598-140-25) / 1 mL in 1 VIAL (43598-140-11)
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	INJECTABLE;INJECTION	080365	ANDA	Dr. Reddy's Laboratories Inc.,	43598-141	43598-141-25	25 VIAL in 1 CARTON (43598-141-25) / 2 mL in 1 VIAL (43598-141-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	No

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