Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010791
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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