FDA.reportPublic FDA data

Application 215025

Type
NDA
Sponsor
MAIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM PHENYLACETATE; SODIUM BENZOATESODIUM PHENYLACETATE;SODIUM BENZOATEINJECTABLE;INJECTION10%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70511-102Sodium Phenylacetate and Sodium BenzoateSodium Phenylacetate and Sodium BenzoateMAIA PHARMACEUTICALSNDACurrent
72266-236Sodium Phenylacetate and Sodium BenzoateSodium Phenylacetate and Sodium BenzoateFOSUN PHARMA USA INCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68912ORIG2021-10-07
67776ORIG2021-06-14
67769ORIG2021-06-11