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Boehringer Ingelheim
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Last Updated: December 3, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212902

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NDA 212902 describes HYDROXYCHLOROQUINE SULFATE, which is a drug marketed by Accord Hlthcare, Alkaloida Zrt, Amneal Pharms Co, Dr Reddys, Hikma Pharms, Invatech, Ipca Labs Ltd, Lupin Ltd, Mylan, Rising, 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-two suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.
Summary for 212902
Applicant:Senores Pharms
Ingredient:hydroxychloroquine sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 212902
Medical Subject Heading (MeSH) Categories for 212902
Suppliers and Packaging for NDA: 212902
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 212902 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-780 59746-780-01 100 TABLET in 1 BOTTLE (59746-780-01)
HYDROXYCHLOROQUINE SULFATE hydroxychloroquine sulfate TABLET;ORAL 212902 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-780 59746-780-05 500 TABLET in 1 BOTTLE (59746-780-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 14, 2020TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

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