FDA.reportPublic FDA data

Application 014901

Type
NDA
Sponsor
APOTHECON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KENALOG-40TRIAMCINOLONE ACETONIDEINJECTABLE;INJECTION40MG/MLYesYes
002KENALOG-80TRIAMCINOLONE ACETONIDEINJECTABLE;INJECTION80MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-0293KENALOG-40TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0293KENALOG-40TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0293KENALOG-40TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0293KENALOG-40TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0293KENALOG-40TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0315KENALOG-80TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0315KENALOG-80TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0315KENALOG-80TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0315KENALOG-80TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.NDACurrent
21695-360KENALOG-40TRIAMCINOLONE ACETONIDERebel DistributorsNDACurrent
49836-004P-Care K40MXTriamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-004P-Care K40MXTriamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-004P-Care K40MXTriamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-005P-Care K40GTriamcinolone Acetonide, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-005P-Care K40GTriamcinolone Acetonide, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-005P-Care K40GTriamcinolone Acetonide, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-006P-Care K40triamcinolone acetonide, povidone-iodine, isopropyl alcoholRX PHARMA-PACK, INC.NDACurrent
49836-006P-Care K40triamcinolone acetonide, povidone-iodine, isopropyl alcoholRX PHARMA-PACK, INC.NDACurrent
49836-006P-Care K40triamcinolone acetonide, povidone-iodine, isopropyl alcoholRX PHARMA-PACK, INC.NDACurrent
49836-007P-Care K80MXTriamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-007P-Care K80MXTriamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-007P-Care K80MXTriamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-008P-Care K80Triamcinolone Acetonide, Povidone Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-008P-Care K80Triamcinolone Acetonide, Povidone Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-008P-Care K80Triamcinolone Acetonide, Povidone Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-009P-Care K80GTriamcinolone Acetonide, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-009P-Care K80GTriamcinolone Acetonide, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-009P-Care K80GTriamcinolone Acetonide, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-524JTT Physicianstriamcinolone acetonide,lidocaine hydrochloride, povidone iodine, ammoniaRX PHARMA-PACK, INC.NDACurrent
49836-524JTT Physicianstriamcinolone acetonide,lidocaine hydrochloride, povidone iodine, ammoniaRX PHARMA-PACK, INC.NDACurrent
50090-0256KENALOG-40TRIAMCINOLONE ACETONIDEA-S Medication SolutionsNDACurrent
50090-0256KENALOG-40TRIAMCINOLONE ACETONIDEA-S Medication SolutionsNDACurrent
50090-0256KENALOG-40TRIAMCINOLONE ACETONIDEA-S Medication SolutionsNDACurrent
50090-0256KENALOG-40TRIAMCINOLONE ACETONIDEA-S Medication SolutionsNDACurrent
50090-0819KENALOG-40TRIAMCINOLONE ACETONIDEA-S Medication SolutionsNDACurrent
50090-0819KENALOG-40TRIAMCINOLONE ACETONIDEA-S Medication SolutionsNDACurrent
50090-0819KENALOG-40TRIAMCINOLONE ACETONIDEA-S Medication SolutionsNDACurrent
50090-2360KENALOG-40TRIAMCINOLONE ACETONIDEA-S Medication SolutionsNDACurrent
50090-2360KENALOG-40TRIAMCINOLONE ACETONIDEA-S Medication SolutionsNDACurrent
55045-3248KENALOG-40TRIAMCINOLONE ACETONIDEDispensing Solutions, Inc.NDACurrent
63187-349Interarticular Joint KitAMMONIA, LIDOCAINE HYDROCHLORIDE ANHYDROUS, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINEProficient Rx LPNDACurrent
63187-661KENALOG-40TRIAMCINOLONE ACETONIDEProficient Rx LPNDACurrent
63187-661KENALOG-40TRIAMCINOLONE ACETONIDEProficient Rx LPNDACurrent
63187-661KENALOG-40TRIAMCINOLONE ACETONIDEProficient Rx LPNDACurrent
69263-820Pro-C-Dure 5 KitkenalogOaklock, LLCNDACurrent
69263-820Pro-C-Dure 5 KitkenalogOaklock, LLCNDACurrent
69263-821Pro-C-Dure 6 KitkenalogOaklock, LLCNDACurrent
69263-821Pro-C-Dure 6 KitkenalogOaklock, LLCNDACurrent
69420-4001BTbupivacaine hydrochloride, triamcinolone acetonide, povidone-iodine and isopropyl alcoholSA3, LLCNDACurrent
69420-4002LTlidocaine hydrochloride, triamcinolone acetonide, povidone-iodine and isopropyl alcoholSA3, LLCNDACurrent
70518-0075KENALOG-40TRIAMCINOLONE ACETONIDEREMEDYREPACK INC.NDACurrent
70518-0075KENALOG-40TRIAMCINOLONE ACETONIDEREMEDYREPACK INC.NDACurrent
70518-0075KENALOG-40TRIAMCINOLONE ACETONIDEREMEDYREPACK INC.NDACurrent
76420-085KENALOG-40TRIAMCINOLONE ACETONIDEAsclemed USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80227SUPPL 2024-11-18
80226SUPPL 2024-11-18
78715SUPPL 2024-06-07
78680SUPPL 2024-06-06
63095SUPPL2020-05-19
63087SUPPL2020-05-19
54712SUPPL2018-06-28
53581SUPPL2018-04-01
53573SUPPL2018-04-01
48411SUPPL2017-05-17
10852SUPPL2014-07-09
391SUPPL2014-07-08
12075SUPPL2011-07-19
33128SUPPL2011-07-18
390SUPPL2011-06-17
33127SUPPL2011-06-16
12074SUPPL2010-02-05
10851SUPPL2010-02-04
40699SUPPL2009-01-12
40698SUPPL2009-01-12
40697SUPPL2009-01-12
20047SUPPL2009-01-12
20046SUPPL2009-01-12
389SUPPL2006-12-04
10850SUPPL2006-11-22