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Details for New Drug Application (NDA): 202152

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NDA 202152 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: 202152

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

Pharmacology for NDA: 202152

Suppliers and Packaging for NDA: 202152

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL 202152 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7986 0615-7986-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7986-05)
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL 202152 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7986 0615-7986-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7986-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Mar 27, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Mar 27, 2012TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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