Details for New Drug Application (NDA): 020639

✉ Email this page to a colleague

NDA 020639 describes SEROQUEL, which is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. Additional details are available on the SEROQUEL profile page.

The generic ingredient in SEROQUEL is quetiapine fumarate. There are fifty-three drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for 020639

Tradename:	SEROQUEL
Applicant:	Astrazeneca
Ingredient:	quetiapine fumarate
Patents:	0

Pharmacology for NDA: 020639

Medical Subject Heading (MeSH) Categories for 020639

Antipsychotic Agents

Suppliers and Packaging for NDA: 020639

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639	NDA	AstraZeneca Pharmaceuticals LP	0310-0271	0310-0271-10	100 TABLET, FILM COATED in 1 BOTTLE (0310-0271-10)
SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639	NDA	AstraZeneca Pharmaceuticals LP	0310-0272	0310-0272-10	100 TABLET, FILM COATED in 1 BOTTLE (0310-0272-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Sep 26, 1997	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Sep 26, 1997	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 200MG BASE
Approval Date:	Sep 26, 1997	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020639

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-004	Dec 20, 1998	⤷ Sign Up	⤷ Sign Up
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-001	Sep 26, 1997	⤷ Sign Up	⤷ Sign Up
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-002	Sep 26, 1997	⤷ Sign Up	⤷ Sign Up
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-005	Jul 26, 2000	⤷ Sign Up	⤷ Sign Up
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-007	Oct 4, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.