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ZYFLO CR
ZYFLO CR - 10122-902-12 - (zileuton)
Drug Information of ZYFLO CR
| Product NDC: | 10122-902 |
| Proprietary Name: | ZYFLO CR |
| Non Proprietary Name: | zileuton |
| Active Ingredient(s): | 600 mg/1 & nbsp; zileuton |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, MULTILAYER, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of ZYFLO CR
| Product NDC: | 10122-902 |
| Labeler Name: | Cornerstone Therapeutics Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022052 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20070530 |
Package Information of ZYFLO CR
| Package NDC: | 10122-902-12 |
| Package Description: | 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (10122-902-12) |
NDC Information of ZYFLO CR
| NDC Code | 10122-902-12 |
| Proprietary Name | ZYFLO CR |
| Package Description | 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (10122-902-12) |
| Product NDC | 10122-902 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | zileuton |
| Dosage Form Name | TABLET, MULTILAYER, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20070530 |
| 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] |
