Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060462
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GARAMYCIN GENTAMICIN SULFATE EQ 0.1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM;TOPICAL Discontinued None No No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
03/15/1966 ORIG-1 Approval

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