Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080557
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYANOCOBALAMIN | CYANOCOBALAMIN | 0.1MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| VIBISONE | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/20/1973 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/14/2005 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 01/08/1999 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1995 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1994 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/2001 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1990 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 09/16/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1983 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
CYANOCOBALAMIN
There are no Therapeutic Equivalents.
VIBISONE
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 | EUGIA PHARMA |
| 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 | 215107 | SAGENT PHARMS INC |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212915 | SANDOZ |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215417 | SOLA PHARMS |
| 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 |
| CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214655 | ZYDUS PHARMS |
| DODEX | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 083022 | ACCORD HLTHCARE |
| VIBISONE | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 080557 | FRESENIUS KABI USA |