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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 040766


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NDA 040766 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 040766
Tradename:HYDROXYCHLOROQUINE SULFATE
Applicant:Ipca Labs Ltd
Ingredient:hydroxychloroquine sulfate
Patents:0
Pharmacology for NDA: 040766
Medical Subject Heading (MeSH) Categories for 040766
Antimalarials
Antirheumatic Agents
Enzyme Inhibitors
Suppliers and Packaging for NDA: 040766
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040766 ANDA Coupler LLC 67046-1523 67046-1523-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1523-3)
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040766 ANDA Bryant Ranch Prepack 71335-3079 71335-3079-1 100 TABLET, FILM COATED in 1 BOTTLE (71335-3079-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jun 14, 2007TE:ABRLD:No

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Preferred Citation:

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