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Last Updated: July 2, 2020

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Details for New Drug Application (NDA): 040657

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NDA 040657 describes HYDROXYCHLOROQUINE SULFATE, which is a drug marketed by Accord Hlthcare, Alkaloida Zrt, Amneal Pharms Co, Appco, Hikma Pharms, Invatech, Ipca Labs Ltd, Laurus Labs Ltd, Lupin Ltd, Mylan, Sandoz, Teva Pharms, Watson Labs, and Zydus Pharms Usa Inc, and is included in fourteen NDAs. It is available from twenty-four 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.
Summary for 040657
Applicant:Zydus Pharms Usa Inc
Ingredient:hydroxychloroquine sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 040657
Medical Subject Heading (MeSH) Categories for 040657
Suppliers and Packaging for NDA: 040657
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA Northstar Rx LLC. 16714-110 16714-110-01 100 TABLET, FILM COATED in 1 BOTTLE (16714-110-01)
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 040657 ANDA Cardinal Health 55154-2074 55154-2074-0 10 BLISTER PACK in 1 BAG (55154-2074-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 21, 2007TE:ABRLD:No

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