Details for New Drug Application (NDA): 003718
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NDA 003718 describes SYNKAYVITE, which is a drug marketed by Roche and is included in one NDA. Additional details are available on the SYNKAYVITE profile page.
The generic ingredient in SYNKAYVITE is menadiol sodium diphosphate. There is one drug master file entry for this compound. Additional details are available on the menadiol sodium diphosphate profile page.
The generic ingredient in SYNKAYVITE is menadiol sodium diphosphate. There is one drug master file entry for this compound. Additional details are available on the menadiol sodium diphosphate profile page.
Summary for 003718
| Tradename: | SYNKAYVITE |
| Applicant: | Roche |
| Ingredient: | menadiol sodium diphosphate |
| Patents: | 0 |
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 006
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 008
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 37.5MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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