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Last Updated: December 25, 2024

Details for New Drug Application (NDA): 077380


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NDA 077380 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 fifty 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-one suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
Summary for 077380
Tradename:QUETIAPINE FUMARATE
Applicant:Dr Reddys Labs Ltd
Ingredient:quetiapine fumarate
Patents:0
Pharmacology for NDA: 077380
Medical Subject Heading (MeSH) Categories for 077380
Suppliers and Packaging for NDA: 077380
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 077380 ANDA Dr.Reddy's Laboratories Limited 55111-169 55111-169-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-169-30)
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 077380 ANDA Dr.Reddy's Laboratories Limited 55111-169 55111-169-60 60 TABLET, FILM COATED in 1 BOTTLE (55111-169-60)

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

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