Application 211390
- Type
- ANDA
- Sponsor
- AIZANT
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 |
|---|---|---|---|---|---|
| 69339-130 | Zileuton | zileuton | DASH Pharmaceutical LLC | ANDA | Current |
| 69339-130 | Zileuton | zileuton | DASH Pharmaceutical LLC | ANDA | Current |
| 69339-130 | Zileuton | zileuton | DASH Pharmaceutical LLC | ANDA | Current |
| 69339-130 | Zileuton | zileuton | DASH Pharmaceutical LLC | ANDA | Current |