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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 201504


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NDA 201504 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 201504
Tradename:QUETIAPINE FUMARATE
Applicant:Alkem Labs Ltd
Ingredient:quetiapine fumarate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201504
Medical Subject Heading (MeSH) Categories for 201504
Suppliers and Packaging for NDA: 201504
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201504 ANDA Major Pharmaceuticals 0904-6638 0904-6638-61 100 BLISTER PACK in 1 CARTON (0904-6638-61) / 1 TABLET in 1 BLISTER PACK
QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201504 ANDA Major Pharmaceuticals 0904-6639 0904-6639-61 100 BLISTER PACK in 1 CARTON (0904-6639-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Feb 12, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Feb 12, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Feb 12, 2013TE:ABRLD:No

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