Last Updated: November 13, 2026

Details for New Drug Application (NDA): 040104

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NDA 040104 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, Ipca Labs Ltd, Laurus, Pharmazone, Sandoz, 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 is one drug master file entry for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.

Summary for 040104

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

Medical Subject Heading (MeSH) Categories for 040104

Antimalarials
Antirheumatic Agents
Enzyme Inhibitors

Profile for product number 001

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

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