FDA.reportPublic FDA data

Application 064093

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GENTAMICIN SULFATEGENTAMICIN SULFATEOINTMENT;OPHTHALMICEQ 0.3% BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-284GentakGentamicin SulfateAkornANDACurrent
17478-284GentakGentamicin SulfateAkorn, Inc.ANDACurrent
17478-284GentakGentamicin SulfateAkornANDACurrent
17478-284GentakGentamicin SulfateAkorn, Inc.ANDACurrent
17478-827GentakGentamicin SulfateAkorn, Inc.ANDACurrent
17478-827GentakGentamicin SulfateAkorn, Inc.ANDACurrent
17478-827GentakGentamicin SulfateAkornANDACurrent
49999-159GentakGentamicin SulfateLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
50090-0251GentakGentamicin SulfateA-S Medication SolutionsANDACurrent
50090-0251GentakGentamicin SulfateA-S Medication SolutionsANDACurrent
50090-4770GentakGentamicin SulfateA-S Medication SolutionsANDACurrent
63187-873GentakGentamicin SulfateProficient Rx LPANDACurrent
63187-873GentakGentamicin SulfateProficient Rx LPANDACurrent
68071-1513GentakGentamicin SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1513GentakGentamicin SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9732GentakGentamicin SulfatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9732GentakGentamicin SulfatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9732GentakGentamicin SulfatePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0633GentakGentamicin SulfateREMEDYREPACK INC.ANDACurrent
70518-0633GentakGentamicin SulfateREMEDYREPACK INC.ANDACurrent