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Application 201528
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
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 |
|---|
| 16729-048 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-048 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-048 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-048 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-049 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-049 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-049 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-049 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-050 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-050 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-050 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-050 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-051 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-051 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-051 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-051 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-129 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-129 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-129 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-129 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-130 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-130 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-130 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |
| 16729-130 | Temozolomide | Temozolomide | Accord Healthcare Inc. | ANDA | Current |