FDA.reportPublic FDA data

Application 091678

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOFLOXACINLEVOFLOXACINSOLUTION;ORAL250MG/10MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0286LevofloxacinLevofloxacinATLANTIC BIOLOGICALS CORP.ANDACurrent
50383-286LevofloxacinLevofloxacinAkornANDACurrent
50383-286LevofloxacinLevofloxacinAkornANDACurrent
50383-286LevofloxacinLevofloxacinHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-286LevofloxacinLevofloxacinHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-286LevofloxacinLevofloxacinHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-286LevofloxacinLevofloxacinAkornANDACurrent
55695-007LevofloxacinLevofloxacinDepartment of State Health Services, Pharmacy BranchANDACurrent