Details for New Drug Application (NDA): 040766

NDA 040766 describes HYDROXYCHLOROQUINE SULFATE, which is a drug marketed by Accord Hlthcare, Alkaloida Zrt, Amneal Pharms Co, Appco, Aurobindo Pharma Usa, Chartwell Rx, Creekwood Pharms, Hikma Pharms, Ipca Labs Ltd, Laurus, Sandoz, Senores Pharms, Teva Pharms, Watson Labs, and Zydus Pharms Usa Inc, and is included in fifteen NDAs. It is available from twenty-five suppliers. Additional details are available on the HYDROXYCHLOROQUINE SULFATE profile page.

The generic ingredient in HYDROXYCHLOROQUINE SULFATE is hydroxychloroquine sulfate. There are fifteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.

Summary for 040766

Tradename:	HYDROXYCHLOROQUINE SULFATE
Applicant:	Ipca Labs Ltd
Ingredient:	hydroxychloroquine sulfate
Patents:	0

Pharmacology for NDA: 040766

Medical Subject Heading (MeSH) Categories for 040766

Antimalarials

Antirheumatic Agents

Enzyme Inhibitors

Suppliers and Packaging for NDA: 040766

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	040766	ANDA	Ipca Laboratories Limited	83980-001	83980-001-01	100 TABLET, FILM COATED in 1 BOTTLE (83980-001-01)
HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	040766	ANDA	Ipca Laboratories Limited	83980-001	83980-001-05	500 TABLET, FILM COATED in 1 BOTTLE (83980-001-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jun 14, 2007	TE:	AB	RLD:	No

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