FDA.reportPublic FDA data

Application 016466

Type
NDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARISTOSPANTRIAMCINOLONE HEXACETONIDEINJECTABLE;INJECTION5MG/MLYesYes
002ARISTOSPANTRIAMCINOLONE HEXACETONIDEINJECTABLE;INJECTION20MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3084AristospanTriamcinolone HexacetonideSandoz IncNDACurrent
0781-3085AristospanTriamcinolone HexacetonideSandoz IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78716SUPPL 2024-06-07
78701SUPPL 2024-06-06
74042SUPPL 2023-04-24
74041SUPPL 2023-04-24
33169SUPPL2014-07-08
448SUPPL2014-07-08
12999SUPPL2009-06-08
447SUPPL2009-06-08
33168SUPPL2009-06-04
10892SUPPL2009-06-04
33167SUPPL2007-03-07
12998SUPPL2007-03-07
33166SUPPL2006-02-07
446SUPPL2006-02-02