Last Updated: June 9, 2026

Details for New Drug Application (NDA): 210577


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NDA 210577 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 210577
Tradename:HYDROXYCHLOROQUINE SULFATE
Applicant:Amneal Pharms Co
Ingredient:hydroxychloroquine sulfate
Patents:0
Pharmacology for NDA: 210577
Medical Subject Heading (MeSH) Categories for 210577
Antimalarials
Antirheumatic Agents
Enzyme Inhibitors
Suppliers and Packaging for NDA: 210577
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210577 ANDA A-S Medication Solutions 50090-4659 50090-4659-2 90 TABLET, FILM COATED in 1 BOTTLE (50090-4659-2)
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210577 ANDA A-S Medication Solutions 50090-4659 50090-4659-3 12 TABLET, FILM COATED in 1 BOTTLE (50090-4659-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 15, 2018TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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