Suppliers and packages for tradename: SIROLIMUS
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SIROLIMUS
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amneal | SIROLIMUS | sirolimus | SOLUTION;ORAL | 211212 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1594-3 | 1 CARTON in 1 KIT (69238-1594-3) / 1 BOTTLE, GLASS in 1 CARTON (69238-1594-6) / 60 mL in 1 BOTTLE, GLASS | 2019-10-25 |
| Apotex | SIROLIMUS | sirolimus | SOLUTION;ORAL | 211406 | ANDA | Apotex Corp | 60505-6197-2 | 1 BOTTLE, GLASS in 1 CARTON (60505-6197-2) / 60 mL in 1 BOTTLE, GLASS | 2020-05-20 |
| Msn | SIROLIMUS | sirolimus | SOLUTION;ORAL | 216728 | ANDA | Novadoz Pharmaceuticals LLC | 72205-099-78 | 1 BOTTLE, GLASS in 1 CARTON (72205-099-78) / 60 mL in 1 BOTTLE, GLASS | 2023-01-19 |
| Novitium Pharma | SIROLIMUS | sirolimus | SOLUTION;ORAL | 211040 | ANDA | VistaPharm, LLC | 66689-347-02 | 1 CARTON in 1 KIT (66689-347-02) / 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE | 2019-01-28 |
| Alkem Labs Ltd | SIROLIMUS | sirolimus | TABLET;ORAL | 214753 | ANDA | Major Pharmaceuticals | 0904-7248-04 | 30 BLISTER PACK in 1 CARTON (0904-7248-04) / 1 TABLET in 1 BLISTER PACK | 2021-03-13 |
| Alkem Labs Ltd | SIROLIMUS | sirolimus | TABLET;ORAL | 214753 | ANDA | Ascend Laboratories, LLC | 67877-746-01 | 100 TABLET in 1 BOTTLE (67877-746-01) | 2021-03-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
