Pharmaceutical drugs supplied by: Sintetica US LLC
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Sintetica US 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 |
|---|---|---|---|---|---|---|---|---|---|
| Msn | BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 209622 | ANDA | Sintetica US LLC | 83090-008-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-008-01) / 3.5 mL in 1 VIAL, SINGLE-DOSE | 2023-07-15 |
| Msn | ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 217413 | ANDA | Sintetica US LLC | 83090-009-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-009-01) / 10 mL in 1 VIAL, SINGLE-DOSE (83090-009-05) | 2023-11-09 |
| Msn | ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 217413 | ANDA | Sintetica US LLC | 83090-009-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83090-009-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83090-009-05) | 2023-11-09 |
| Msn | ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 217413 | ANDA | Sintetica US LLC | 83090-010-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-010-01) / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05) | 2023-11-09 |
| Msn | ARSENIC TRIOXIDE | arsenic trioxide | INJECTABLE;INJECTION | 217413 | ANDA | Sintetica US LLC | 83090-010-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83090-010-10) / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05) | 2023-11-09 |
| Hainan Poly Pharm | DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 215890 | ANDA | Sintetica US LLC | 83090-011-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-011-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2023-11-05 |
| Hainan Poly | LACOSAMIDE | lacosamide | SOLUTION;INTRAVENOUS | 217311 | ANDA | Sintetica US LLC | 83090-012-10 | 10 VIAL, GLASS in 1 CARTON (83090-012-10) / 20 mL in 1 VIAL, GLASS | 2024-03-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
