FDA.reportPublic FDA data

Application 212991

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOBRAMYCIN AND DEXAMETHASONEDEXAMETHASONE; TOBRAMYCINSUSPENSION/DROPS;OPHTHALMIC0.1%;0.3%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1373tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1373tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1373tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1374tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1374tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1374tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1375tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1375tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1375tobramycin and dexamethasonetobramycin and dexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent