FDA.reportPublic FDA data

Application 076128

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-410OfloxacinOfloxacinBausch & Lomb IncorporatedANDACurrent
24208-410OfloxacinOfloxacinBausch & Lomb IncorporatedANDACurrent
33261-737OfloxacinOfloxacinAidarex Pharmaceuticals LLCANDACurrent
42254-257OfloxacinOfloxacinRebel Distributors CorpANDACurrent
50090-1736OfloxacinOfloxacinA-S Medication SolutionsANDACurrent
50090-1736OfloxacinOfloxacinA-S Medication SolutionsANDACurrent
53002-1604OfloxacinOfloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-1604OfloxacinOfloxacinRPK Pharmaceuticals, Inc.ANDACurrent
63187-472OfloxacinOfloxacinProficient Rx LPANDACurrent
63187-472OfloxacinOfloxacinProficient Rx LPANDACurrent
63187-472OfloxacinOfloxacinProficient Rx LPANDACurrent