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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204253


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NDA 204253 describes QUETIAPINE FUMARATE, which is a drug marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Anchen Pharms, Aurobindo Pharma, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, Par Pharm, 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, Jubilant Generics, Mylan Pharms Inc, Sandoz, Sun Pharm, Teva Pharms, Torrent Pharms Ltd, and Zennova, and is included in thirty-six 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-seven suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
Summary for 204253
Tradename:QUETIAPINE FUMARATE
Applicant:Macleods Pharms Ltd
Ingredient:quetiapine fumarate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204253
Medical Subject Heading (MeSH) Categories for 204253
Suppliers and Packaging for NDA: 204253
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 204253 ANDA Macleods Pharmaceuticals Limited 33342-134 33342-134-09 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-134-09)
QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 204253 ANDA Macleods Pharmaceuticals Limited 33342-134 33342-134-15 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-134-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 150MG BASE
Approval Date:Nov 29, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG BASE
Approval Date:Nov 29, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 300MG BASE
Approval Date:Nov 29, 2017TE:ABRLD:No

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