FDA.reportPublic FDA data

Application 076616

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OFLOXACINOFLOXACINSOLUTION/DROPS;OTIC0.3%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-881OfloxacinOfloxaxinRebel Distributors CorpANDACurrent
50090-3836OfloxacinOfloxaxinA-S Medication SolutionsANDACurrent
50090-3836OfloxacinOfloxaxinA-S Medication SolutionsANDACurrent
50090-3836OfloxacinOfloxaxinA-S Medication SolutionsANDACurrent
50383-025OfloxacinOfloxaxinHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-025OfloxacinOfloxaxinHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-025OfloxacinOfloxaxinHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-025OfloxacinOfloxaxinAkornANDACurrent
68788-0617OfloxacinOfloxaxinPreferred Pharmaceuticals, Inc.ANDACurrent
71205-682OfloxacinOfloxaxinProficient Rx LPANDACurrent