Details for New Drug Application (NDA): 206254
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NDA 206254 describes ROMIDEPSIN, which is a drug marketed by Fresenius Kabi Usa and Teva Pharms Usa Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the ROMIDEPSIN profile page.
The generic ingredient in ROMIDEPSIN is romidepsin. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the romidepsin profile page.
The generic ingredient in ROMIDEPSIN is romidepsin. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the romidepsin profile page.
Summary for 206254
| Tradename: | ROMIDEPSIN |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | romidepsin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206254
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROMIDEPSIN | romidepsin | POWDER;INTRAVENOUS | 206254 | ANDA | Fresenius Kabi USA, LLC | 63323-926 | 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) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 10MG/VIAL | ||||
| Approval Date: | Oct 12, 2021 | TE: | AP | RLD: | No | ||||
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