Details for New Drug Application (NDA): 212670
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NDA 212670 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 212670
| Tradename: | ZILEUTON |
| Applicant: | Strides Pharma |
| Ingredient: | zileuton |
| Patents: | 0 |
Pharmacology for NDA: 212670
| Mechanism of Action | 5-Lipoxygenase Inhibitors |
| Physiological Effect | Decreased Leukotriene Production |
Suppliers and Packaging for NDA: 212670
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZILEUTON | zileuton | TABLET, EXTENDED RELEASE;ORAL | 212670 | ANDA | Golden State Medical Supply, Inc. | 51407-741 | 51407-741-12 | 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (51407-741-12) |
| ZILEUTON | zileuton | TABLET, EXTENDED RELEASE;ORAL | 212670 | ANDA | Strides Pharma Science Limited | 64380-189 | 64380-189-01 | 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (64380-189-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
| Approval Date: | Dec 16, 2019 | TE: | AB | RLD: | No | ||||
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