Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 003718
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SYNKAYVITE | MENADIOL SODIUM DIPHOSPHATE | 5MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| SYNKAYVITE | MENADIOL SODIUM DIPHOSPHATE | 10MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| SYNKAYVITE | MENADIOL SODIUM DIPHOSPHATE | 37.5MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| SYNKAYVITE | MENADIOL SODIUM DIPHOSPHATE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/15/1941 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/08/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/27/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/27/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |