Details for New Drug Application (NDA): 080557
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NDA 080557 describes VIBISONE, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from two suppliers. Additional details are available on the VIBISONE profile page.
The generic ingredient in VIBISONE is cyanocobalamin. There are nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.
The generic ingredient in VIBISONE is cyanocobalamin. There are nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.
Summary for 080557
| Tradename: | VIBISONE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | cyanocobalamin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 080557
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYANOCOBALAMIN | cyanocobalamin | INJECTABLE;INJECTION | 080557 | ANDA | Fresenius Kabi USA, LLC | 63323-044 | 63323-044-01 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-01) / 1 mL in 1 VIAL, MULTI-DOSE (63323-044-00) |
| CYANOCOBALAMIN | cyanocobalamin | INJECTABLE;INJECTION | 080557 | ANDA | Fresenius Kabi USA, LLC | 63323-044 | 63323-044-44 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-44) / 1 mL in 1 VIAL, MULTI-DOSE (63323-044-41) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 0.1MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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