FDA.reportPublic FDA data

Application 212715

Type
ANDA
Sponsor
PADAGIS US

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
0574-4031TOBRAMYCIN AND DEXAMETHASONEtobramycin and dexamethasonePadagis US LLCANDACurrent
63629-9570TOBRAMYCIN AND DEXAMETHASONEtobramycin and dexamethasoneBryant Ranch PrepackANDACurrent
63629-9571TOBRAMYCIN AND DEXAMETHASONEtobramycin and dexamethasoneBryant Ranch PrepackANDACurrent
63629-9572TOBRAMYCIN AND DEXAMETHASONEtobramycin and dexamethasoneBryant Ranch PrepackANDACurrent
68071-2772TOBRAMYCIN AND DEXAMETHASONEtobramycin and dexamethasoneNuCare Pharmaceuticasl,Inc.ANDACurrent