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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 020639

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NDA 020639 describes SEROQUEL, which is a drug marketed by Cheplapharm and is included in two NDAs. It is available from two suppliers. 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. Fifty suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for 020639

Tradename:	SEROQUEL
Applicant:	Cheplapharm
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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-001	Sep 26, 1997	4,879,288*PED	⤷ Start Trial
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-005	Jul 26, 2000	4,879,288*PED	⤷ Start Trial
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-007	Oct 4, 2005	4,879,288*PED	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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