Details for New Drug Application (NDA): 215742
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NDA 215742 describes ZILEUTON, which is a drug marketed by Aizant, Annora Pharma, Lupin Ltd, Rising, Strides Pharma, and Teva Pharms Usa, and is included in six NDAs. It is available from five suppliers. Additional details are available on the ZILEUTON profile page.
The generic ingredient in ZILEUTON is zileuton. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the zileuton profile page.
The generic ingredient in ZILEUTON is zileuton. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the zileuton profile page.
Summary for 215742
| Tradename: | ZILEUTON |
| Applicant: | Annora Pharma |
| Ingredient: | zileuton |
| Patents: | 0 |
Pharmacology for NDA: 215742
| Mechanism of Action | 5-Lipoxygenase Inhibitors |
| Physiological Effect | Decreased Leukotriene Production |
Suppliers and Packaging for NDA: 215742
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZILEUTON | zileuton | TABLET, EXTENDED RELEASE;ORAL | 215742 | ANDA | Camber Pharmaceuticals, Inc. | 31722-044 | 31722-044-12 | 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-044-12) |
| ZILEUTON | zileuton | TABLET, EXTENDED RELEASE;ORAL | 215742 | ANDA | NorthStar RxLLC | 72603-246 | 72603-246-01 | 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-246-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
| Approval Date: | Oct 11, 2022 | TE: | AB | RLD: | No | ||||
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