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Details for New Drug Application (NDA): 203390

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NDA 203390 describes QUETIAPINE FUMARATE, which is a drug marketed by Alkem Labs Ltd, Lupin Ltd, Roxane, Mylan Pharms Inc, Teva Pharms, Jubilant Generics, Accord Hlthcare, Macleods Pharms Ltd, Apotex Inc, Actavis Grp Ptc, Torrent Pharms Ltd, Unichem Labs Ltd, Sandoz, Dr Reddys Labs Ltd, Accord Hlthcare Inc, Aurobindo Pharma Ltd, Alembic Pharms Ltd, and Sun Pharma Global, and is included in nineteen 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 drug master file entries for this compound. Fifty-two suppliers are listed for this compound. There are nineteen tentative approvals for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for NDA: 203390

Tradename:
QUETIAPINE FUMARATE
Applicant:
Alembic Pharms Ltd
Ingredient:
quetiapine fumarate
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203390

Suppliers and Packaging for NDA: 203390

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL 203390 ANDA Alembic Pharmaceuticals Limited 46708-134 46708-134-10 100 TABLET, FILM COATED in 1 CARTON (46708-134-10)
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL 203390 ANDA Alembic Pharmaceuticals Limited 46708-134 46708-134-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-134-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Oct 28, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Oct 28, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Oct 28, 2014TE:ABRLD:No


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