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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215417
Company: SOLA PHARMS
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
04/15/2022 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 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 INC
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
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