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Generated: April 26, 2017

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Details for New Drug Application (NDA): 090120

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NDA 090120 describes QUETIAPINE FUMARATE, which is a drug marketed by Alkem Labs Ltd, Lupin Ltd, West-ward Pharms Int, 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, 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-one 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: 090120

Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090120

Suppliers and Packaging for NDA: 090120

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
quetiapine fumarate
TABLET;ORAL 090120 ANDA West-Ward Pharmaceuticals Corp 0054-0220 0054-0220-20 10 BLISTER PACK in 1 CARTON (0054-0220-20) > 10 TABLET in 1 BLISTER PACK
quetiapine fumarate
TABLET;ORAL 090120 ANDA West-Ward Pharmaceuticals Corp 0054-0220 0054-0220-25 100 TABLET in 1 BOTTLE (0054-0220-25)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Mar 27, 2012TE:ABRLD:No

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