Details for New Drug Application (NDA): 089515
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NDA 089515 describes VINBLASTINE SULFATE, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, Hikma, and Hospira, and is included in four NDAs. It is available from one supplier. Additional details are available on the VINBLASTINE SULFATE profile page.
The generic ingredient in VINBLASTINE SULFATE is vinblastine sulfate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the vinblastine sulfate profile page.
The generic ingredient in VINBLASTINE SULFATE is vinblastine sulfate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the vinblastine sulfate profile page.
Summary for 089515
| Tradename: | VINBLASTINE SULFATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | vinblastine sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 089515
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VINBLASTINE SULFATE | vinblastine sulfate | INJECTABLE;INJECTION | 089515 | ANDA | Fresenius Kabi USA, LLC | 63323-278 | 63323-278-10 | 1 VIAL, MULTI-DOSE in 1 BOX (63323-278-10) / 10 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Apr 29, 1987 | TE: | RLD: | No | |||||
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