Last Updated: May 10, 2026

Details for New Drug Application (NDA): 040133

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NDA 040133 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-eight 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. Thirty-one suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.

Summary for 040133

Tradename:	HYDROXYCHLOROQUINE SULFATE
Applicant:	Watson Labs
Ingredient:	hydroxychloroquine sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 040133

Antimalarials
Antirheumatic Agents
Enzyme Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Nov 30, 1995	TE:		RLD:	No

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