FDA.reportPublic FDA data

Application 078559

Type
ANDA
Sponsor
FDC LTD

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
50090-5425OfloxacinOfloxacinA-S Medication SolutionsANDACurrent
52959-763ofloxacinofloxacinH.J. Harkins Company, Inc.ANDACurrent
55545-1003OfloxacinOfloxacinFDC LimitedANDACurrent
63187-734OfloxacinOfloxacinProficient Rx LPANDACurrent
63187-734OfloxacinOfloxacinProficient Rx LPANDACurrent
63187-734OfloxacinOfloxacinProficient Rx LPANDACurrent
64980-515OfloxacinOfloxacinRising Pharmaceuticals, Inc.ANDACurrent
64980-515OfloxacinOfloxacinRising Pharmaceuticals, Inc.ANDACurrent
64980-515OfloxacinOfloxacinRising Pharmaceuticals, Inc.ANDACurrent
68071-4832OfloxacinOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4832OfloxacinOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5150OfloxacinOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5150OfloxacinOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8264OfloxacinOfloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8993OfloxacinOfloxacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-8993OfloxacinOfloxacinPreferred Pharmaceuticals Inc.ANDACurrent
70518-1892OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent
70518-1892OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent
70518-1892OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent
70518-1892OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent
70518-1892OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent
70518-2037OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent
70518-2037OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent
70518-2037OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent
70518-2037OfloxacinOfloxacinREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44632ORIG2009-03-03