FDA.reportPublic FDA data

Application 206968

Type
NDA
Sponsor
INNOPHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHENACETAMINOPHENSOLUTION;INTRAVENOUS1GM/100ML (10MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9386AcetaminophenAcetaminophenHikma Pharmaceuticals USA Inc.NDACurrent
0143-9386AcetaminophenAcetaminophenHikma Pharmaceuticals USA Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78583SUPPL 2024-05-30
78580SUPPL 2024-05-30
74028ORIG 2023-04-20
71250ORIG2022-06-08
71247ORIG2022-06-07