FDA.reportPublic FDA data

Application 206242

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.5% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-643MOXIFLOXACINMOXIFLOXACINNorthStar Rx LLCANDACurrent
16714-643MOXIFLOXACINMOXIFLOXACINNorthStar Rx LLCANDACurrent
65862-840MOXIFLOXACINMOXIFLOXACINAurobindo Pharma LimitedANDACurrent
65862-840MOXIFLOXACINMOXIFLOXACINAurobindo Pharma LimitedANDACurrent
65862-840MOXIFLOXACINMOXIFLOXACINAurobindo Pharma LimitedANDACurrent
65862-840MOXIFLOXACINMOXIFLOXACINAurobindo Pharma LimitedANDACurrent
72189-076MOXIFLOXACINMOXIFLOXACINDIRECT RXANDACurrent