FDA.reportPublic FDA data

Application 012041

Type
NDA
Sponsor
APOTHECON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KENALOG-10TRIAMCINOLONE ACETONIDEINJECTABLE;INJECTION10MG/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-0494KENALOG-10TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0494KENALOG-10TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0494KENALOG-10TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0494KENALOG-10TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.NDACurrent
50090-0295KENALOG-10TRIAMCINOLONE ACETONIDEA-S Medication SolutionsNDACurrent
50090-0295KENALOG-10TRIAMCINOLONE ACETONIDEA-S Medication SolutionsNDACurrent
68258-8903KENALOG-10TRIAMCINOLONE ACETONIDEDispensing Solutions, Inc.NDACurrent
70518-2460KENALOG-10TRIAMCINOLONE ACETONIDEREMEDYREPACK INC.NDACurrent
70518-2460KENALOG-10TRIAMCINOLONE ACETONIDEREMEDYREPACK INC.NDACurrent
70518-2460KENALOG-10TRIAMCINOLONE ACETONIDEREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79707SUPPL 2024-09-24
79706SUPPL 2024-09-24
78709SUPPL 2024-06-07
78676SUPPL 2024-06-06
54731SUPPL2018-06-29
54701SUPPL2018-06-27
53583SUPPL2018-04-01
53572SUPPL2018-04-01
33071SUPPL2014-07-09
11985SUPPL2014-07-08
40677SUPPL2012-02-28
11984SUPPL2011-07-19
33070SUPPL2011-07-18
302SUPPL2011-06-17
10791SUPPL2011-06-16
301SUPPL2010-02-05
33069SUPPL2010-02-04
11983SUPPL2006-12-04
33068SUPPL2006-11-22