FDA.reportPublic FDA data

Application 064048

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GENTAMICIN SULFATEGENTAMICIN SULFATESOLUTION/DROPS;OPHTHALMICEQ 0.3% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-580Gentamicin SulfateGentamicin SulfateBausch & Lomb IncorporatedANDACurrent
24208-580Gentamicin SulfateGentamicin SulfateBausch & Lomb IncorporatedANDACurrent
24208-580Gentamicin SulfateGentamicin SulfateBausch & Lomb IncorporatedANDACurrent
24208-580Gentamicin SulfateGentamicin SulfateBausch & Lomb IncorporatedANDACurrent
45865-672Gentamicin SulfateGentamicin SulfateMedsource PharmaceuticalsANDACurrent
45865-672Gentamicin SulfateGentamicin SulfateMedsource PharmaceuticalsANDACurrent
50090-0249Gentamicin SulfateGentamicin SulfateA-S Medication SolutionsANDACurrent
50090-0569Gentamicin SulfateGentamicin SulfateA-S Medication SolutionsANDACurrent
50436-6752Gentamicin SulfateGentamicin SulfateUnit Dose ServicesANDACurrent
50436-6754Gentamicin SulfateGentamicin SulfateUnit Dose ServicesANDACurrent
63187-560Gentamicin SulfateGentamicin SulfateProficient Rx LPANDACurrent
63187-560Gentamicin SulfateGentamicin SulfateProficient Rx LPANDACurrent
63187-560Gentamicin SulfateGentamicin SulfateProficient Rx LPANDACurrent
68788-0633Gentamicin SulfateGentamicin SulfatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0633Gentamicin SulfateGentamicin SulfatePreferred Pharmaceuticals, Inc.ANDACurrent
72189-359Gentamicin Sulfate Opth SolutionGentamicin Sulfate Opth SolutionDirect_RxANDACurrent
76420-254Gentamicin SulfateGentamicin SulfateAsclemed USA, Inc.ANDACurrent