Details for New Drug Application (NDA): 213163
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NDA 213163 describes ZAFIRLUKAST, which is a drug marketed by Annora Pharma, Aurobindo Pharma, Dr Reddys Labs Ltd, and Rising Pharms, and is included in four NDAs. It is available from five suppliers. Additional details are available on the ZAFIRLUKAST profile page.
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.
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 213163
| Tradename: | ZAFIRLUKAST |
| Applicant: | Aurobindo Pharma |
| Ingredient: | zafirlukast |
| Patents: | 0 |
Pharmacology for NDA: 213163
| Mechanism of Action | Cytochrome P450 2C9 Inhibitors Leukotriene Receptor Antagonists |
Suppliers and Packaging for NDA: 213163
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZAFIRLUKAST | zafirlukast | TABLET;ORAL | 213163 | ANDA | Aurobindo Pharma Limited | 59651-291 | 59651-291-60 | 60 TABLET, FILM COATED in 1 BOTTLE (59651-291-60) |
| ZAFIRLUKAST | zafirlukast | TABLET;ORAL | 213163 | ANDA | Aurobindo Pharma Limited | 59651-292 | 59651-292-60 | 60 TABLET, FILM COATED in 1 BOTTLE (59651-292-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 27, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Nov 27, 2023 | TE: | AB | RLD: | No | ||||
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