FDA.reportPublic FDA data

Application 209510

Type
NDA
Sponsor
ACACIA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BARHEMSYSAMISULPRIDESOLUTION;INTRAVENOUS5MG/2ML (2.5MG/ML)YesYes
002BARHEMSYSAMISULPRIDESOLUTION;INTRAVENOUS10MG/4ML (2.5MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71390-125BarhemsysAmisulprideAcacia Pharma LtdNDACurrent
71390-125BarhemsysAmisulprideAcacia Pharma LtdNDACurrent
71390-125BarhemsysAmisulprideAcacia Pharma LtdNDACurrent
71390-125BarhemsysAmisulprideAcacia Pharma LtdNDACurrent
71390-125BarhemsysAmisulprideAcacia Pharma LtdNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72084SUPPL2022-09-15
72081SUPPL2022-09-15
69816SUPPL2022-01-06
69815SUPPL2022-01-06
67604SUPPL2021-05-27
67600SUPPL2021-05-26
65973SUPPL2021-01-25
65968SUPPL2021-01-25
62356ORIG2020-03-30
61983ORIG2020-02-27
61975ORIG2020-02-26