FDA.reportPublic FDA data

Application 208778

Type
ANDA
Sponsor
GLAND 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
50090-6248Moxifloxacin OphthalmicMoxifloxacin OphthalmicA-S Medication SolutionsANDACurrent
68083-210Moxifloxacin Ophthalmic SolutionMoxifloxacin OphthalmicGland Pharma LimitedANDACurrent
68083-210Moxifloxacin Ophthalmic SolutionMoxifloxacin OphthalmicGland Pharma LimitedANDACurrent
72266-158Moxifloxacin Ophthalmic SolutionMoxifloxacin OphthalmicFosun Pharma USA Inc.ANDACurrent