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Express Scripts
Boehringer Ingelheim

Last Updated: September 24, 2020

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, Novast Labs, and Teva Pharms, and is included in five NDAs. It is available from four 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. Six suppliers are listed for this compound. Additional details are available on the quinine sulfate profile page.
Summary for 203112
Applicant:Lupin Ltd
Ingredient:quinine sulfate
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 68180-560-01 100 CAPSULE in 1 BOTTLE (68180-560-01)
QUININE SULFATE quinine sulfate CAPSULE;ORAL 203112 ANDA Lupin Pharmaceuticals, Inc. 68180-560 68180-560-02 500 CAPSULE in 1 BOTTLE (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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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

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