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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 020547

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NDA 020547 describes ACCOLATE, which is a drug marketed by Strides Pharma Intl and is included in one NDA. It is available from three suppliers. Additional details are available on the ACCOLATE profile page.

The generic ingredient in ACCOLATE is zafirlukast. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the zafirlukast profile page.

Summary for 020547

Tradename:	ACCOLATE
Applicant:	Strides Pharma Intl
Ingredient:	zafirlukast
Patents:	0

Pharmacology for NDA: 020547

Mechanism of Action	Cytochrome P450 2C9 Inhibitors Leukotriene Receptor Antagonists

Suppliers and Packaging for NDA: 020547

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACCOLATE	zafirlukast	TABLET;ORAL	020547	NDA	AvKARE	42291-970	42291-970-60	60 TABLET, COATED in 1 BOTTLE (42291-970-60)
ACCOLATE	zafirlukast	TABLET;ORAL	020547	NDA	AvKARE	42291-971	42291-971-60	60 TABLET, COATED in 1 BOTTLE (42291-971-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Sep 26, 1996	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 17, 1999	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020547

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	⤷ Get Started Free	⤷ Get Started Free
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	⤷ Get Started Free	⤷ Get Started Free
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	⤷ Get Started Free	⤷ Get Started Free
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	⤷ Get Started Free	⤷ Get Started Free
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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