Suppliers and packages for generic ingredient: ROMIDEPSIN
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ROMIDEPSIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bristol-myers | ISTODAX | romidepsin | POWDER;INTRAVENOUS | 022393 | NDA | Celgene Corporation | 59572-984-01 | 1 KIT in 1 CARTON (59572-984-01) * 2.2 mL in 1 VIAL, GLASS (59572-962-10) * 2.4 mL in 1 VIAL, GLASS (59572-973-02) | 2010-01-04 |
| Fresenius Kabi Usa | ROMIDEPSIN | romidepsin | POWDER;INTRAVENOUS | 206254 | ANDA | Fresenius Kabi USA, LLC | 63323-926-88 | 1 KIT in 1 CARTON (63323-926-88) * 2 mL in 1 VIAL, SINGLE-DOSE (63323-925-17) * 2.2 mL in 1 VIAL, SINGLE-DOSE (63323-922-03) | 2021-10-12 |
| Teva Pharms Usa Inc | ROMIDEPSIN | romidepsin | SOLUTION;INTRAVENOUS | 208574 | NDA | Teva Parenteral Medicines, Inc. | 0703-4004-01 | 1 VIAL in 1 CARTON (0703-4004-01) / 5.5 mL in 1 VIAL | 2020-04-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
