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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 201691


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NDA 201691 describes HYDROXYCHLOROQUINE SULFATE, which is a drug marketed by Accord Hlthcare, Alkaloida Zrt, Amneal Pharms Co, Anda Repository, Appco, Aurobindo Pharma Usa, Chartwell Rx, Creekwood Pharms, Hikma Pharms, Ipca Labs Ltd, Laurus, Sandoz, Teva Pharms, Watson Labs, and Zydus Pharms Usa Inc, and is included in fifteen NDAs. It is available from twenty-seven 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 suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.
Summary for 201691
Tradename:HYDROXYCHLOROQUINE SULFATE
Applicant:Alkaloida Zrt
Ingredient:hydroxychloroquine sulfate
Patents:0
Pharmacology for NDA: 201691
Medical Subject Heading (MeSH) Categories for 201691
Antimalarials
Antirheumatic Agents
Enzyme Inhibitors
Suppliers and Packaging for NDA: 201691
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 201691 ANDA Sun Pharmaceutical Industries, Inc. 57664-761 57664-761-13 500 TABLET in 1 BOTTLE (57664-761-13)
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 201691 ANDA Sun Pharmaceutical Industries, Inc. 57664-761 57664-761-88 100 TABLET in 1 BOTTLE (57664-761-88)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 8, 2018TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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