FDA.reportPublic FDA data

Application 208521

Type
ANDA
Sponsor
MAIA PHARMS INC

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
67457-844Sodium Phenylacetate and Sodium BenzoateSodium Phenylacetate and Sodium BenzoateMylan Institutional LLCANDACurrent
67457-844Sodium Phenylacetate and Sodium BenzoateSodium Phenylacetate and Sodium BenzoateMylan Institutional LLCANDACurrent
70511-101SODIUM PHENYLACETATE AND SODIUM BENZOATEsodium phenylacetate and sodium benzoateMAIA PHARMACEUTICALS, INCANDACurrent
70511-101SODIUM PHENYLACETATE AND SODIUM BENZOATEsodium phenylacetate and sodium benzoateMAIA PHARMACEUTICALS, INCANDACurrent
72266-247Sodium Phenylacetate and Sodium BenzoateSodium Phenylacetate and Sodium BenzoateFOSUN PHARMA USA INCANDACurrent
72266-247Sodium Phenylacetate and Sodium BenzoateSodium Phenylacetate and Sodium BenzoateFOSUN PHARMA USA INCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48349ORIG2017-05-10