Product NDC: | 10122-901 |
Proprietary Name: | ZYFLO |
Non Proprietary Name: | zileuton |
Active Ingredient(s): | 600 mg/1 & nbsp; zileuton |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 10122-901 |
Labeler Name: | Cornerstone Therapeutics Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020471 |
Marketing Category: | NDA |
Start Marketing Date: | 19961206 |
Package NDC: | 10122-901-12 |
Package Description: | 120 TABLET in 1 BOTTLE (10122-901-12) |
NDC Code | 10122-901-12 |
Proprietary Name | ZYFLO |
Package Description | 120 TABLET in 1 BOTTLE (10122-901-12) |
Product NDC | 10122-901 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | zileuton |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 19961206 |
Marketing Category Name | NDA |
Labeler Name | Cornerstone Therapeutics Inc. |
Substance Name | ZILEUTON |
Strength Number | 600 |
Strength Unit | mg/1 |
Pharmaceutical Classes | 5-Lipoxygenase Inhibitor [EPC],5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE] |