FDA.reportPublic FDA data

Application 064054

Type
ANDA
Sponsor
ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GENTAMICIN SULFATEGENTAMICIN SULFATEOINTMENT;TOPICALEQ 0.1% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0682Gentamicin SulfateGentamicin SulfateCosette Pharmaceuticals, Inc.ANDACurrent
0713-0682Gentamicin SulfateGentamicin SulfateCosette Pharmaceuticals, Inc.ANDACurrent
0713-0682Gentamicin SulfateGentamicin SulfateCosette Pharmaceuticals, Inc.ANDACurrent
0713-0682Gentamicin SulfateGentamicin SulfateG&W Laboratories, Inc.ANDACurrent
71205-560Gentamicin SulfateGentamicin SulfateProficient Rx LPANDACurrent