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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 211816

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NDA 211816 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the chlorpromazine hydrochloride profile page.

Summary for 211816

Tradename:	CHLORPROMAZINE HYDROCHLORIDE
Applicant:	Eugia Pharma
Ingredient:	chlorpromazine hydrochloride
Patents:	0

Pharmacology for NDA: 211816

Suppliers and Packaging for NDA: 211816

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	INJECTABLE;INJECTION	211816	ANDA	Eugia US LLC	55150-318	55150-318-25	25 AMPULE in 1 CARTON (55150-318-25) / 1 mL in 1 AMPULE (55150-318-01)
CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	INJECTABLE;INJECTION	211816	ANDA	Eugia US LLC	55150-319	55150-319-25	25 AMPULE in 1 CARTON (55150-319-25) / 2 mL in 1 AMPULE (55150-319-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Jul 7, 2020	TE:	AP	RLD:	No

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