Last Updated: June 24, 2026

Details for New Drug Application (NDA): 040081


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NDA 040081 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 040081
Tradename:HYDROXYCHLOROQUINE SULFATE
Applicant:Teva Pharms
Ingredient:hydroxychloroquine sulfate
Patents:0
Pharmacology for NDA: 040081
Medical Subject Heading (MeSH) Categories for 040081
Antimalarials
Antirheumatic Agents
Enzyme Inhibitors
Suppliers and Packaging for NDA: 040081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040081 ANDA Teva Pharmaceuticals USA, Inc. 0093-2401 0093-2401-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-2401-01)
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040081 ANDA Bryant Ranch Prepack 71335-1771 71335-1771-1 100 TABLET, FILM COATED in 1 BOTTLE (71335-1771-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 30, 1994TE:ABRLD:No

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Preferred Citation:

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