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Details for New Drug Application (NDA): 040766

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NDA 040766 describes HYDROXYCHLOROQUINE SULFATE, which is a drug marketed by Sandoz, Watson Labs, Zydus Pharms Usa Inc, Hikma Pharms Llc, Ipca Labs Ltd, Mylan, and Teva Pharms, and is included in eight NDAs. It is available from twenty-six suppliers. Additional details are available on the HYDROXYCHLOROQUINE SULFATE profile page.

The generic ingredient in HYDROXYCHLOROQUINE SULFATE is hydroxychloroquine sulfate. There are thirteen 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 NDA: 040766

Ipca Labs Ltd
hydroxychloroquine sulfate
Therapeutic Class:Antiparasitics

Pharmacology for NDA: 040766

Suppliers and Packaging for NDA: 040766

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydroxychloroquine sulfate
TABLET;ORAL 040766 ANDA Blenheim Pharmacal, Inc. 10544-578 10544-578-90 90 TABLET, FILM COATED in 1 BOTTLE (10544-578-90)
hydroxychloroquine sulfate
TABLET;ORAL 040766 ANDA Rebel Distributors Corp 21695-486 21695-486-30 30 TABLET, FILM COATED in 1 BOTTLE (21695-486-30)

Summary for product number 001

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

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