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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Farmers Insurance
Johnson and Johnson
Daiichi Sankyo
Queensland Health

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203729

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NDA 203729 describes QUININE SULFATE, which is a drug marketed by Amneal Pharms, Lupin Ltd, Mylan Pharms Inc, Riconpharma Llc, and Teva Pharms, and is included in five NDAs. It is available from six suppliers. Additional details are available on the QUININE SULFATE profile page.

The generic ingredient in QUININE SULFATE is quinine sulfate. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the quinine sulfate profile page.
Summary for 203729
Applicant:Amneal Pharms
Ingredient:quinine sulfate
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Pharmacology for NDA: 203729
Medical Subject Heading (MeSH) Categories for 203729
Suppliers and Packaging for NDA: 203729
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUININE SULFATE quinine sulfate CAPSULE;ORAL 203729 ANDA Amneal Pharmaceuticals of New York, LLC 65162-811 N 65162-811-03
QUININE SULFATE quinine sulfate CAPSULE;ORAL 203729 ANDA Amneal Pharmaceuticals of New York, LLC 65162-811 N 65162-811-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength324MG
Approval Date:Jul 15, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Queensland Health
Argus Health

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