Details for New Drug Application (NDA): 210959

NDA 210959 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 210959

Tradename:	HYDROXYCHLOROQUINE SULFATE
Applicant:	Laurus
Ingredient:	hydroxychloroquine sulfate
Patents:	0

Pharmacology for NDA: 210959

Medical Subject Heading (MeSH) Categories for 210959

Antimalarials

Antirheumatic Agents

Enzyme Inhibitors

Suppliers and Packaging for NDA: 210959

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	210959	ANDA	Rising Pharma Holdings, Inc.	16571-112	16571-112-01	100 TABLET, FILM COATED in 1 BOTTLE (16571-112-01)
HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	210959	ANDA	Rising Pharma Holdings, Inc.	16571-112	16571-112-06	60 TABLET, FILM COATED in 1 BOTTLE (16571-112-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jan 15, 2019	TE:	AB	RLD:	No

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