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Last Updated: April 26, 2024

Details for New Drug Application (NDA): 203112

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NDA 203112 describes QUININE SULFATE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Usa, Lupin Ltd, 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. Five 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 203112

Medical Subject Heading (MeSH) Categories for 203112

Analgesics, Non-Narcotic
Antimalarials
Muscle Relaxants, Central

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	68180-560-06	30 CAPSULE in 1 BOTTLE (68180-560-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	324MG
Approval Date:	Apr 24, 2015	TE:	AB	RLD:	No

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