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Last Updated: September 24, 2020

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

Profile for product number 001

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

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