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Generated: December 18, 2017

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. Ten suppliers are listed for this compound. Additional details are available on the quinine sulfate profile page.

Summary for 203729

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 65162-811-03 30 CAPSULE in 1 BOTTLE (65162-811-03)
QUININE SULFATE quinine sulfate CAPSULE;ORAL 203729 ANDA Amneal Pharmaceuticals of New York, LLC 65162-811 65162-811-09 90 CAPSULE in 1 BOTTLE (65162-811-09)

Summary for product number 001

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


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