FDA.reportPublic FDA data

Application 211525

Type
ANDA
Sponsor
AMNEAL

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
50090-5670OfloxacinOfloxacin OticA-S Medication SolutionsANDACurrent
68071-2454OfloxacinOfloxacin OticNuCare Pharmaceuticals,Inc.ANDACurrent
69238-1615OfloxacinOfloxacin OticAmneal Pharmaceuticals NY LLCANDACurrent
69238-1615OfloxacinOfloxacin OticAmneal Pharmaceuticals NY LLCANDACurrent
69238-1615OfloxacinOfloxacin OticAmneal Pharmaceuticals NY LLCANDACurrent
69238-1616OfloxacinOfloxacin OticAmneal Pharmaceuticals NY LLCANDACurrent
69238-1616OfloxacinOfloxacin OticAmneal Pharmaceuticals NY LLCANDACurrent
69238-1616OfloxacinOfloxacin OticAmneal Pharmaceuticals NY LLCANDACurrent
69238-1616OfloxacinOfloxacin OticAmneal Pharmaceuticals NY LLCANDACurrent