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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203359

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NDA 203359 describes QUETIAPINE FUMARATE, which is a drug marketed by Lupin Ltd, Alkem Labs Ltd, West-ward Pharms Int, Mylan Pharms Inc, Intellipharmaceutics, Teva Pharms, Jubilant Generics, Accord Hlthcare, Macleods Pharms Ltd, Pharmadax Inc, Apotex Inc, Actavis Grp Ptc, Torrent Pharms Ltd, Unichem Labs Ltd, Sandoz, Dr Reddys Labs Ltd, Par Pharm, Aurobindo Pharma Ltd, Alembic Pharms Ltd, and Sun Pharma Global, and is included in twenty-three 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-one drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for NDA: 203359

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203359

Suppliers and Packaging for NDA: 203359

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL 203359 ANDA Macleods Pharmaceuticals Limited 33342-099 33342-099-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-099-11)
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL 203359 ANDA Macleods Pharmaceuticals Limited 33342-099 33342-099-12 10 BLISTER PACK in 1 CARTON (33342-099-12) > 10 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:May 17, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:May 17, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:May 17, 2016TE:ABRLD:No


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