FDA.report

Application 076527

Type
ANDA
Sponsor
APOTEX INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001OFLOXACINOFLOXACINSOLUTION/DROPS;OTIC0.3%NoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1090Ofloxacin OticOfloxacinA-S Medication SolutionsANDACurrent
50090-1090Ofloxacin OticOfloxacinA-S Medication SolutionsANDACurrent
50090-1090Ofloxacin OticOfloxacinA-S Medication SolutionsANDACurrent
53002-2604Ofloxacin OticOfloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-2604Ofloxacin OticOfloxacinRPK Pharmaceuticals, Inc.ANDACurrent
60505-0363Ofloxacin OticOfloxacinApotex Corp.ANDACurrent
60505-0363Ofloxacin OticOfloxacinApotex Corp.ANDACurrent
60505-0363Ofloxacin OticOfloxacinApotex Corp.ANDACurrent
63187-184Ofloxacin OticOfloxacinProficient Rx LPANDACurrent
63187-184Ofloxacin OticOfloxacinProficient Rx LPANDACurrent
63187-184Ofloxacin OticOfloxacinProficient Rx LPANDACurrent
63629-8716Ofloxacin OticOfloxacinBryant Ranch PrepackANDACurrent
63629-8716Ofloxacin OticOfloxacinBryant Ranch PrepackANDACurrent
68071-1588Ofloxacin OticOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1588Ofloxacin OticOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1588Ofloxacin OticOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1630Ofloxacin OticOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1630Ofloxacin OticOfloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9504Ofloxacin OticOfloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
72189-108OFLOXACIN OTICOFLOXACINDIRECT RXANDACurrent
72189-108OFLOXACIN OTICOFLOXACINDIRECT RXANDACurrent

Documents

DocumentSubmission typeDate
43086ORIG2011-09-16