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Last Updated: September 27, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204372

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NDA 204372 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 204372
Tradename:QUININE SULFATE
Applicant:Novast Labs
Ingredient:quinine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204372
Medical Subject Heading (MeSH) Categories for 204372
Suppliers and Packaging for NDA: 204372
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUININE SULFATE quinine sulfate CAPSULE;ORAL 204372 ANDA Ingenus Pharmaceuticals, LLC 50742-238 50742-238-30 30 CAPSULE in 1 BOTTLE, PLASTIC (50742-238-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength324MG
Approval Date:Jul 22, 2015TE:ABRLD:No

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