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Generated: April 30, 2017

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Details for New Drug Application (NDA): 203729

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

The generic ingredient in QUININE SULFATE is quinine sulfate. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the quinine sulfate profile page.

Summary for NDA: 203729

Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details

Pharmacology for NDA: 203729

Suppliers and Packaging for NDA: 203729

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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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