Application 213438
- Type
- ANDA
- Sponsor
- LEADING PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HYDROXYUREA | HYDROXYUREA | CAPSULE;ORAL | 500MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10135-702 | Hydroxyurea | Hydroxyurea | Marlex Pharmaceuticals, Inc. | ANDA | Current |
| 69315-164 | HYDROXYUREA | HYDROXYUREA | Leading Pharma, LLC | ANDA | Current |
| 69315-164 | HYDROXYUREA | HYDROXYUREA | Leading Pharma, LLC | ANDA | Current |
| 69315-164 | HYDROXYUREA | HYDROXYUREA | Leading Pharma, LLC | ANDA | Current |
| 69315-164 | HYDROXYUREA | HYDROXYUREA | Leading Pharma, LLC | ANDA | Current |
| 70518-3615 | HYDROXYUREA | HYDROXYUREA | REMEDYREPACK INC. | ANDA | Current |