You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
Boehringer Ingelheim
Moodys
Medtronic
Mallinckrodt

Last Updated: September 24, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203112

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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
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
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

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Johnson and Johnson
Baxter
Merck
Mallinckrodt

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.