You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Details for New Drug Application (NDA): 203729

✉ Email this page to a colleague

« Back to Dashboard

NDA 203729 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 203729

Tradename:	QUININE SULFATE
Applicant:	Amneal Pharms
Ingredient:	quinine sulfate
Patents:	0

Pharmacology for NDA: 203729

Medical Subject Heading (MeSH) Categories for 203729

Analgesics, Non-Narcotic
Antimalarials
Muscle Relaxants, Central

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:	RX	Dosage:	CAPSULE;ORAL			Strength	324MG
Approval Date:	Jul 15, 2015	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.