You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 4, 2024

Details for New Drug Application (NDA): 020547

✉ Email this page to a colleague

« Back to Dashboard

NDA 020547 describes ACCOLATE, which is a drug marketed by Strides Pharma 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
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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	⤷ Sign Up	⤷ Sign Up
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	⤷ Sign Up	⤷ Sign Up
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	⤷ Sign Up	⤷ Sign Up
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	⤷ Sign Up	⤷ Sign Up
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	⤷ Sign Up	⤷ Sign Up
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	⤷ Sign Up	⤷ Sign Up
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	⤷ 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.