Suppliers and packages for generic ingredient: 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 |
|---|---|---|---|---|---|---|---|---|---|
| Nobelpharma | HYFTOR | sirolimus | GEL;TOPICAL | 213478 | NDA | Nobelpharma America, LLC | 73683-101-10 | 1 TUBE in 1 CARTON (73683-101-10) / 10 g in 1 TUBE | 2022-03-23 |
| Aadi | FYARRO | sirolimus | POWDER;INTRAVENOUS | 213312 | NDA | Aadi Bioscience | 80803-153-50 | 1 VIAL, SINGLE-USE in 1 CARTON (80803-153-50) / 20 mL in 1 VIAL, SINGLE-USE | 2021-12-06 |
| Pf Prism Cv | RAPAMUNE | sirolimus | SOLUTION;ORAL | 021083 | NDA | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1030-06 | 1 CARTON in 1 KIT (0008-1030-06) / 1 BOTTLE, GLASS in 1 CARTON (0008-1030-04) / 60 mL in 1 BOTTLE, GLASS | 1999-09-01 |
| Pf Prism Cv | RAPAMUNE | sirolimus | SOLUTION;ORAL | 021083 | NDA AUTHORIZED GENERIC | Greenstone LLC | 59762-1205-6 | 1 CARTON in 1 KIT (59762-1205-6) / 1 BOTTLE, GLASS in 1 CARTON (59762-1205-4) / 60 mL in 1 BOTTLE, GLASS | 2019-07-22 |
| 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 |
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