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Medtronic
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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203112

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NDA 203112 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 203112
Tradename:QUININE SULFATE
Applicant:Lupin Ltd
Ingredient:quinine sulfate
Patents:0
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Pharmacology for NDA: 203112
Medical Subject Heading (MeSH) Categories for 203112
Suppliers and Packaging for NDA: 203112
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUININE SULFATE quinine sulfate CAPSULE;ORAL 203112 ANDA Lupin Pharmaceuticals, Inc. 68180-560 N 68180-560-01
QUININE SULFATE quinine sulfate CAPSULE;ORAL 203112 ANDA Lupin Pharmaceuticals, Inc. 68180-560 N 68180-560-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength324MG
Approval Date:Apr 24, 2015TE:ABRLD:No

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