Details for New Drug Application (NDA): 212475
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The generic ingredient in ZAFIRLUKAST 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 212475
Tradename: | ZAFIRLUKAST |
Applicant: | Annora Pharma |
Ingredient: | zafirlukast |
Patents: | 0 |
Pharmacology for NDA: 212475
Mechanism of Action | Cytochrome P450 2C9 Inhibitors Leukotriene Receptor Antagonists |
Suppliers and Packaging for NDA: 212475
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZAFIRLUKAST | zafirlukast | TABLET;ORAL | 212475 | ANDA | Camber Pharmaceuticals, Inc. | 31722-007 | 31722-007-01 | 10 BLISTER PACK in 1 CARTON (31722-007-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
ZAFIRLUKAST | zafirlukast | TABLET;ORAL | 212475 | ANDA | Camber Pharmaceuticals, Inc. | 31722-007 | 31722-007-05 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-007-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 10, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Sep 10, 2020 | TE: | AB | RLD: | No |
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