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Last Updated: February 20, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210441

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NDA 210441 describes HYDROXYCHLOROQUINE SULFATE, which is a drug marketed by Alkaloida Zrt, Amneal Pharms Co, Hikma Pharms, Invatech, Ipca Labs Ltd, Laurus Labs Ltd, Lupin Ltd, Mylan, Sandoz, Teva Pharms, Twi Pharms, Watson Labs, and Zydus Pharms Usa Inc, and is included in thirteen NDAs. It is available from twenty-three 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-five suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.
Summary for 210441
Applicant:Twi Pharms
Ingredient:hydroxychloroquine sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 210441
Medical Subject Heading (MeSH) Categories for 210441
Suppliers and Packaging for NDA: 210441
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210441 ANDA Dr. Reddy's Laboratories Inc. 43598-721 43598-721-01 100 TABLET in 1 BOTTLE (43598-721-01)
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 210441 ANDA Dr. Reddy's Laboratories Inc. 43598-721 43598-721-05 500 TABLET in 1 BOTTLE (43598-721-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 1, 2018TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Boehringer Ingelheim

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