Application 070259
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOLAZAMIDE | TOLAZAMIDE | TABLET;ORAL | 250MG | No | No |
| 003 | TOLAZAMIDE | TOLAZAMIDE | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-0217 | Tolazamide | tolazamide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0217 | Tolazamide | tolazamide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0551 | Tolazamide | tolazamide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0551 | Tolazamide | tolazamide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 55289-265 | Tolazamide | tolazamide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |