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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 040274


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NDA 040274 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 040274
Tradename:HYDROXYCHLOROQUINE SULFATE
Applicant:Aurobindo Pharma Usa
Ingredient:hydroxychloroquine sulfate
Patents:0
Pharmacology for NDA: 040274
Medical Subject Heading (MeSH) Categories for 040274
Antimalarials
Antirheumatic Agents
Enzyme Inhibitors
Suppliers and Packaging for NDA: 040274
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040274 ANDA Aurobindo Pharma Limited 59651-889 59651-889-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59651-889-01)
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040274 ANDA Aurobindo Pharma Limited 59651-889 59651-889-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59651-889-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 29, 1998TE:ABRLD:No

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Preferred Citation:

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