FDA.reportPublic FDA data

Application 018878

Type
NDA
Sponsor
RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDOCININDOMETHACIN SODIUMINJECTABLE;INJECTIONEQ 1MG BASE/VIALYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66913SUPPL2021-03-30
66901SUPPL2021-03-29
16078SUPPL2010-01-26
33630SUPPL2010-01-20
1113SUPPL2007-01-25
11355SUPPL2007-01-16
16077SUPPL2006-02-08
33629SUPPL2006-02-07
16076SUPPL2003-05-30
1112SUPPL2003-05-30