Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204829
Company: MYLAN LABS LTD
Company: MYLAN LABS LTD
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 |
---|---|---|---|---|---|---|---|
06/05/2017 | ORIG-1 | Approval |
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 | 214390 | GLAND PHARMA LTD |
CYANOCOBALAMIN | CYANOCOBALAMIN | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217839 | MANKIND PHARMA |
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 |