Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209255
Company: VITRUVIAS THERAP
Company: VITRUVIAS THERAP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 12/18/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CYANOCOBALAMIN
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 080737 | AM REGENT |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213874 | AUROBINDO PHARMA LTD |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214390 | GLAND PHARMA LTD |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204829 | MYLAN LABS LTD |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212915 | SANDOZ INC |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206503 | SOMERSET THERAPS LLC |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209429 | SOMERSET THERAPS LLC |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209255 | VITRUVIAS THERAP |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 080515 | WEST-WARD PHARMS INT |
| VIBISONE | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 080557 | FRESENIUS KABI USA |
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