Application 204929
- Type
- ANDA
- Sponsor
- RISING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZILEUTON | ZILEUTON | TABLET, EXTENDED RELEASE;ORAL | 600MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64980-206 | Zileuton | Zileuton | Rising Pharmaceuticals, Inc. | ANDA | Current |