FDA.reportPublic FDA data

Application 209469

Type
ANDA
Sponsor
ALEMBIC PHARMS 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
50090-4781Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmicA-S Medication SolutionsANDACurrent
50090-4781Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmicA-S Medication SolutionsANDACurrent
50090-4781Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmicA-S Medication SolutionsANDACurrent
53002-2626Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmicRPK Pharmaceuticals, Inc.ANDACurrent
62332-505Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmic solutionAlembic Pharmaceuticals Inc.ANDACurrent
62332-505Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmic solutionAlembic Pharmaceuticals Inc.ANDACurrent
62332-505Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmic solutionAlembic Pharmaceuticals Inc.ANDACurrent
62332-505Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmic solutionAlembic Pharmaceuticals Inc.ANDACurrent
62332-505Moxifloxacin ophthalmic solutionMoxifloxacin ophthalmic solutionAlembic Pharmaceuticals Inc.ANDACurrent