FDA.reportPublic FDA data

Application 207096

Type
ANDA
Sponsor
AILEX PHARMS 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
13811-705SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoateTrigen Laboratories, LLCANDACurrent
13811-705SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoateTrigen Laboratories, LLCANDACurrent
13811-705SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoateTrigen Laboratories, LLCANDACurrent
69784-810SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoateWoodward Pharma Services LLCANDACurrent
69784-810SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoateWoodward Pharma Services LLCANDACurrent
69784-811SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoateWoodward Pharma Services LLCANDACurrent
69784-811SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoateWoodward Pharma Services LLCANDACurrent
70556-100SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoateAilex Pharmaceuticals, LLCANDACurrent
70556-100SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoateAilex Pharmaceuticals, LLCANDACurrent
70556-100SODIUM PHENYLACETATE and SODIUM BENZOATEsodium phenylacetate and sodium benzoateAilex Pharmaceuticals, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40582ORIG2016-03-04
32844ORIG2016-02-26