Application 215307
- Type
- ANDA
- Sponsor
- NOVITIUM PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIGOXIN | DIGOXIN | TABLET;ORAL | 0.125MG | No | No |
| 002 | DIGOXIN | DIGOXIN | TABLET;ORAL | 0.25MG | No | No |
| 003 | DIGOXIN | DIGOXIN | TABLET;ORAL | 0.0625MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10135-747 | Digoxin | Digoxin | Marlex Pharmaceuticals, Inc. | ANDA | Current |
| 10135-748 | Digoxin | Digoxin | Marlex Pharmaceuticals, Inc. | ANDA | Current |
| 70954-200 | Digoxin | Digoxin | Novitium Pharma LLC | ANDA | Current |
| 70954-201 | Digoxin | Digoxin | Novitium Pharma LLC | ANDA | Current |
| 70954-201 | Digoxin | Digoxin | Novitium Pharma LLC | ANDA | Current |
| 70954-201 | Digoxin | Digoxin | Novitium Pharma LLC | ANDA | Current |
| 70954-202 | Digoxin | Digoxin | Novitium Pharma LLC | ANDA | Current |
| 70954-202 | Digoxin | Digoxin | Novitium Pharma LLC | ANDA | Current |
| 70954-202 | Digoxin | Digoxin | Novitium Pharma LLC | ANDA | Current |