Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010791
Company: BEL MAR
Company: BEL MAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RUBIVITE | CYANOCOBALAMIN | 0.05MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| RUBIVITE | CYANOCOBALAMIN | 0.1MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| RUBIVITE | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| RUBIVITE | CYANOCOBALAMIN | 0.03MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| RUBIVITE | CYANOCOBALAMIN | 0.12MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 07/14/1958 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
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