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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 090681


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NDA 090681 describes QUETIAPINE FUMARATE, which is a drug marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Aurobindo Pharma, Endo Operations, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, Pharmadax Inc, Prinston Inc, Rising, Sciegen Pharms Inc, Unichem, Actavis Grp Ptc, Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Jubilant Generics, Norvium Bioscience, Sandoz, Sun Pharm, Teva Pharms, and Torrent Pharms Ltd, and is included in thirty-seven NDAs. It is available from forty-nine 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. Fifty suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
Summary for 090681
Tradename:QUETIAPINE FUMARATE
Applicant:Accord Hlthcare
Ingredient:quetiapine fumarate
Patents:0
Pharmacology for NDA: 090681
Medical Subject Heading (MeSH) Categories for 090681
Suppliers and Packaging for NDA: 090681
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 090681 ANDA Accord Healthcare Inc. 16729-095 16729-095-12 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-095-12)
QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 090681 ANDA Accord Healthcare Inc. 16729-096 16729-096-12 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-096-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 150MG BASE
Approval Date:May 9, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG BASE
Approval Date:May 9, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 300MG BASE
Approval Date:May 9, 2017TE:ABRLD:No

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