FDA.reportPublic FDA data

Application 020645

Type
NDA
Sponsor
MEDICIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMMONULSODIUM BENZOATE; SODIUM PHENYLACETATESOLUTION;INTRAVENOUS10%;10% (5GM/50ML;5GM/50ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0010Ammonulsodium phenylacetate and sodium benzoateBausch Health US LLCNDACurrent
0187-0010Ammonulsodium phenylacetate and sodium benzoateValeant Pharmaceuticals North America LLCNDACurrent
0187-0010Ammonulsodium phenylacetate and sodium benzoateBausch Health US LLCNDACurrent
0187-0010Ammonulsodium phenylacetate and sodium benzoateBausch Health US LLCNDACurrent
0187-0010Ammonulsodium phenylacetate and sodium benzoateBausch Health US LLCNDACurrent
0187-0010Ammonulsodium phenylacetate and sodium benzoateBausch Health Americas, Inc.NDACurrent
0187-0010Ammonulsodium phenylacetate and sodium benzoateBausch Health US LLCNDACurrent
62592-720Ammonulsodium phenylacetate and sodium benzoateUcyclyd Pharma Inc.NDACurrent
68682-001Sodium Phenylacetate and Sodium Benzoatesodium phenylacetate and sodium benzoateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-001SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-001Sodium Phenylacetate and Sodium Benzoatesodium phenylacetate and sodium benzoateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65747SUPPL2020-12-28
65713SUPPL2020-12-23
35069SUPPL2011-07-06
2993SUPPL2011-07-05
41519ORIG2007-06-04
44457ORIG2005-02-23
35068ORIG2005-02-23
25434ORIG2005-02-23