Details for New Drug Application (NDA): 204929
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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.
Pharmacology for NDA: 204929
Mechanism of Action | 5-Lipoxygenase Inhibitors |
Physiological Effect | Decreased Leukotriene Production |
Suppliers and Packaging for NDA: 204929
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZILEUTON | zileuton | TABLET, EXTENDED RELEASE;ORAL | 204929 | ANDA | Rising Pharma Holdings, Inc. | 64980-206 | 64980-206-12 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-206-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
Approval Date: | Mar 17, 2017 | TE: | AB | RLD: | No |
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