FDA.reportPublic FDA data

Application 205880

Type
ANDA
Sponsor
NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM BENZOATE; SODIUM PHENYLACETATESOLUTION;INTRAVENOUS10%;10% (5GM/50ML;5GM/50ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-396SODIUM PHENYLACETATE AND SODIUM BENZOATEsodium phenylacetate and sodium benzoateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-396SODIUM PHENYLACETATE AND SODIUM BENZOATEsodium phenylacetate and sodium benzoateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-396SODIUM PHENYLACETATE AND SODIUM BENZOATEsodium phenylacetate and sodium benzoateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-396SODIUM PHENYLACETATE AND SODIUM BENZOATEsodium phenylacetate and sodium benzoateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-396SODIUM PHENYLACETATE AND SODIUM BENZOATEsodium phenylacetate and sodium benzoateZydus Pharmaceuticals USA Inc.ANDACurrent
68475-001Sodium Phenylacetate and sodium benzoateSodium Phenylacetate and sodium benzoateNavinta LLCANDACurrent
68475-001Sodium Phenylacetate and sodium benzoateSodium Phenylacetate and sodium benzoateNavinta LLCANDACurrent
68475-001Sodium Phenylacetate and sodium benzoateSodium Phenylacetate and sodium benzoateNavinta LLCANDACurrent
68475-001Sodium Phenylacetate and sodium benzoateSodium Phenylacetate and sodium benzoateNavinta LLCANDACurrent
68475-001Sodium Phenylacetate and sodium benzoateSodium Phenylacetate and sodium benzoateNavinta LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45688ORIG2016-10-27
45522ORIG2016-10-12