Application 213328
- Type
- ANDA
- Sponsor
- NIVAGEN PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No |
| 002 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No |
| 003 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No |
| 004 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No |
| 005 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No |
| 006 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 75834-132 | temozolomide | temozolomide | Nivagen Pharmaceuticals, Inc. | ANDA | Current |
| 75834-142 | temozolomide | temozolomide | Nivagen Pharmaceuticals, Inc. | ANDA | Current |
| 75834-143 | temozolomide | temozolomide | Nivagen Pharmaceuticals, Inc. | ANDA | Current |
| 75834-144 | temozolomide | temozolomide | Nivagen Pharmaceuticals, Inc. | ANDA | Current |
| 75834-145 | temozolomide | temozolomide | Nivagen Pharmaceuticals, Inc. | ANDA | Current |
| 75834-146 | temozolomide | temozolomide | Nivagen Pharmaceuticals, Inc. | ANDA | Current |