FDA.reportPublic FDA data

Application 076361

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOFLOXACINLEVOFLOXACINTABLET;ORAL250MGNoNo
002LEVOFLOXACINLEVOFLOXACINTABLET;ORAL500MGNoNo
003LEVOFLOXACINLEVOFLOXACINTABLET;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-024LevofloxacinLevofloxacinRebel Distributors CorpANDACurrent
21695-027LevofloxacinLevofloxacinRebel Distributors CorpANDACurrent
21695-041LevofloxacinLevofloxacinRebel Distributors CorpANDACurrent
45865-758LevofloxacinLevofloxacinMedsource PharmaceuticalsANDACurrent
45865-758LevofloxacinLevofloxacinMedsource PharmaceuticalsANDACurrent
61919-867LevofloxacinLevofloxacinDirect RXANDACurrent
61919-992LevofloxacinLevofloxacinDirect RXANDACurrent
63187-047LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-048LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63629-4642LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
76519-1001LevofloxacinLevofloxacinH.J. Harkins Company, Inc.ANDACurrent