FDA.reportPublic FDA data

Application 076407

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OFLOXACINOFLOXACINSOLUTION/DROPS;OPHTHALMIC0.3%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-7189OfloxacinOfloxacinHenry Schein Inc.ANDACurrent
0404-7189OfloxacinOfloxacinHenry Schein Inc.ANDACurrent
0404-7189OfloxacinOfloxacinHenry Schein Inc.ANDACurrent
13985-602OfloxacinOfloxacinMWIANDACurrent
13985-602OfloxacinOfloxacinMWIANDACurrent
13985-602OfloxacinOfloxacinMWIANDACurrent
17478-713OfloxacinOfloxacinAkornANDACurrent
17478-713OfloxacinOfloxacinAkorn, Inc.ANDACurrent
17478-713OfloxacinOfloxacinAkornANDACurrent
17478-713OfloxacinOfloxacinAkorn, Inc.ANDACurrent
17478-713OfloxacinOfloxacinAkorn, Inc.ANDACurrent
50090-0891OfloxacinOfloxacinA-S Medication SolutionsANDACurrent
50090-0891OfloxacinOfloxacinA-S Medication SolutionsANDACurrent
50090-0891OfloxacinOfloxacinA-S Medication SolutionsANDACurrent
50090-1346OfloxacinOfloxacinA-S Medication SolutionsANDACurrent
50090-1346OfloxacinOfloxacinA-S Medication SolutionsANDACurrent
50090-1346OfloxacinOfloxacinA-S Medication SolutionsANDACurrent
50090-1346OfloxacinOfloxacinA-S Medication SolutionsANDACurrent
50090-1346OfloxacinOfloxacinA-S Medication SolutionsANDACurrent
50436-0713OfloxacinOfloxacinUnit Dose ServicesANDACurrent
53002-1324OfloxacinOfloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-1324OfloxacinOfloxacinRPK Pharmaceuticals, Inc.ANDACurrent
55700-066OfloxacinOfloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-066OfloxacinOfloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-066OfloxacinOfloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-175OFLOXACINOFLOXACINDIRECT RXANDACurrent
63187-662OfloxacinOfloxacinProficient Rx LPANDACurrent
63187-662OfloxacinOfloxacinProficient Rx LPANDACurrent
63187-662OfloxacinOfloxacinProficient Rx LPANDACurrent
68071-1607OfloxacinOfloxacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1607OfloxacinOfloxacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2834OfloxacinOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4055OfloxacinOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7003OfloxacinOfloxacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7003OfloxacinOfloxacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7003OfloxacinOfloxacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-8195OfloxacinOfloxacinPreferred Pharmaceuticals Inc.ANDACurrent
70518-0192OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent
70518-0192OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent
70518-0192OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent
70518-0308OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent