Pharmaceutical drugs supplied by: OPKO Pharmaceuticals, LLC
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OPKO Pharmaceuticals, LLC
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Eirgen | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 203898 | ANDA | OPKO Pharmaceuticals, LLC | 70301-2005-1 | 5 PACKET in 1 CARTON (70301-2005-1) / 1 CAPSULE in 1 PACKET | 2026-07-31 |
| Eirgen | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 203898 | ANDA | OPKO Pharmaceuticals, LLC | 70301-2005-2 | 14 PACKET in 1 CARTON (70301-2005-2) / 1 CAPSULE in 1 PACKET | 2026-07-31 |
| Eirgen | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 203898 | ANDA | OPKO Pharmaceuticals, LLC | 70301-2007-1 | 5 PACKET in 1 CARTON (70301-2007-1) / 1 CAPSULE in 1 PACKET | 2026-07-31 |
| Eirgen | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 203898 | ANDA | OPKO Pharmaceuticals, LLC | 70301-2007-2 | 14 PACKET in 1 CARTON (70301-2007-2) / 1 CAPSULE in 1 PACKET | 2026-07-31 |
| Eirgen | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 203898 | ANDA | OPKO Pharmaceuticals, LLC | 70301-2009-1 | 5 PACKET in 1 CARTON (70301-2009-1) / 1 CAPSULE in 1 PACKET | 2026-07-31 |
| Eirgen | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 203898 | ANDA | OPKO Pharmaceuticals, LLC | 70301-2009-2 | 14 PACKET in 1 CARTON (70301-2009-2) / 1 CAPSULE in 1 PACKET | 2026-07-31 |
| Eirgen | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 203898 | ANDA | OPKO Pharmaceuticals, LLC | 70301-2011-1 | 5 PACKET in 1 CARTON (70301-2011-1) / 1 CAPSULE in 1 PACKET | 2026-07-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
