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Application 204639
- Type
- ANDA
- Sponsor
- CHEMI SPA
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 |
|---|
| 42737-101 | TEMOZOLOMIDE | temozolomide | Chemi Pharma LLC | ANDA | Current |
| 42737-102 | TEMOZOLOMIDE | temozolomide | Chemi Pharma LLC | ANDA | Current |
| 42737-103 | TEMOZOLOMIDE | temozolomide | Chemi Pharma LLC | ANDA | Current |
| 42737-104 | TEMOZOLOMIDE | temozolomide | Chemi Pharma LLC | ANDA | Current |
| 42737-105 | TEMOZOLOMIDE | temozolomide | Chemi Pharma LLC | ANDA | Current |
| 42737-106 | TEMOZOLOMIDE | temozolomide | Chemi Pharma LLC | ANDA | Current |
| 59923-703 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-703 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-703 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-703 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-704 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-704 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-704 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-704 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-705 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-705 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-705 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-705 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-706 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-706 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-706 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-706 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-707 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-707 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-707 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-707 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-708 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-708 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-708 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-708 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-709 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-709 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-709 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-709 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-710 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-710 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-710 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-710 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-711 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-711 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-711 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-711 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-712 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-712 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-712 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-712 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-713 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-713 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-713 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |
| 59923-713 | TEMOZOLOMIDE | temozolomide | Areva Pharmaceuticals | ANDA | Current |