➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Johnson and Johnson
Harvard Business School
McKesson
McKinsey

Last Updated: May 28, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201109


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 201109 describes QUETIAPINE FUMARATE, which is a drug marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Anchen Pharms, Aurobindo Pharma Ltd, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, Par Pharm, Pharmadax Inc, Sciegen Pharms Inc, Actavis Grp Ptc, Alembic Pharms Ltd, Alkem Labs Ltd, Dr Reddys Labs Ltd, Hikma, Jubilant Generics, Mylan Pharms Inc, Sandoz, Sun Pharm, Teva Pharms, Torrent Pharms Ltd, Unichem Labs Ltd, and Zennova, and is included in thirty-one NDAs. It is available from forty-six suppliers. Additional details are available on the QUETIAPINE FUMARATE profile page.

The generic ingredient in QUETIAPINE FUMARATE is quetiapine fumarate. There are fifty-three drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
Summary for 201109
Tradename:QUETIAPINE FUMARATE
Applicant:Lupin Ltd
Ingredient:quetiapine fumarate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201109
Medical Subject Heading (MeSH) Categories for 201109
Suppliers and Packaging for NDA: 201109
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201109 ANDA Cardinal Health 55154-4685 55154-4685-0 10 BLISTER PACK in 1 BAG (55154-4685-0) > 1 TABLET in 1 BLISTER PACK
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201109 ANDA American Health Packaging 60687-327 60687-327-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-327-01) > 1 TABLET in 1 BLISTER PACK (60687-327-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Mar 27, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Mar 27, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Mar 27, 2012TE:ABRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Baxter
Moodys
McKesson
AstraZeneca
Johnson and Johnson
Medtronic

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.