GENOPTIC (gentamicin-sulfate) ANDA 062452

by ALLERGAN

attributevalue
Drug NameGENOPTIC
Application Number062452
Active Ingredient(s)GENTAMICIN SULFATE
CompanyALLERGAN
Dosages/Routes/Forms
Drug NameActive Ingredient(s)StrengthForm/RouteMarketing StatusRLDTE Code
GENOPTICGENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS; OPHTHALMIC10AT
Approval History
DateSupplement No.ActionDocuments
Aug 15, 2001020Facility Addition
    Oct 10, 1984000Approval
      Jul 03, 2002021Microbiology
        Nov 22, 1988004Chemistry
          Nov 15, 2002022Microbiology
            Apr 11, 1991005Chemistry
              Apr 05, 1989006Chemistry
                Feb 26, 1991007Chemistry
                  Feb 28, 1992008Labeling
                    Sep 27, 1993009Labeling
                      Sep 27, 1994010Chemistry
                        Jul 01, 1994011Chemistry
                          Jan 31, 1995012Labeling
                            Apr 03, 1998013Microbiology
                              Oct 22, 1997014Chemistry
                                Feb 24, 1998015Chemistry
                                  Oct 16, 1998016Chemistry
                                    Dec 08, 2000017Facility Addition