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Details for New Drug Application (NDA): 022047

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NDA 022047 describes SEROQUEL XR, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from five suppliers. There is one patent protecting this drug and four Paragraph IV challenges. Additional details are available on the SEROQUEL XR profile page.

The generic ingredient in SEROQUEL XR 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: 022047

Tradename:
SEROQUEL XR
Applicant:
Astrazeneca
Ingredient:
quetiapine fumarate
Patents:1
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022047

Suppliers and Packaging for NDA: 022047

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEROQUEL XR
quetiapine fumarate
TABLET, EXTENDED RELEASE;ORAL 022047 NDA AstraZeneca Pharmaceuticals LP 0310-0280 0310-0280-39 100 TABLET, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (0310-0280-39)
SEROQUEL XR
quetiapine fumarate
TABLET, EXTENDED RELEASE;ORAL 022047 NDA AstraZeneca Pharmaceuticals LP 0310-0280 0310-0280-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0280-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:May 17, 2007TE:RLD:No
Patent:5,948,437*PEDPatent Expiration:Nov 28, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG BASE
Approval Date:May 17, 2007TE:RLD:Yes
Patent:5,948,437*PEDPatent Expiration:Nov 28, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 300MG BASE
Approval Date:May 17, 2007TE:RLD:No
Patent:5,948,437*PEDPatent Expiration:Nov 28, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 022047

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
SEROQUEL XR
quetiapine fumarate
TABLET, EXTENDED RELEASE;ORAL022047-001May 17, 20074,879,288*PED► subscribe
Astrazeneca
SEROQUEL XR
quetiapine fumarate
TABLET, EXTENDED RELEASE;ORAL022047-004May 17, 20074,879,288*PED► subscribe
Astrazeneca
SEROQUEL XR
quetiapine fumarate
TABLET, EXTENDED RELEASE;ORAL022047-003May 17, 20074,879,288*PED► subscribe
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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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