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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 020547


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NDA 020547 describes ACCOLATE, which is a drug marketed by Strides Pharma and is included in one NDA. It is available from four 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. Eight 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 020547
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:RXDosage:TABLET;ORALStrength20MG
Approval Date:Sep 26, 1996TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 17, 1999TE:ABRLD:Yes

Expired US Patents for NDA 020547

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

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