Details for New Drug Application (NDA): 020547
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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
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 | 020547-001 | 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 | 020547-003 | Sep 17, 1999 | ⤷ 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 |
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