Application 014901
- Type
- NDA
- Sponsor
- APOTHECON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | INJECTABLE;INJECTION | 40MG/ML | Yes | Yes |
| 002 | KENALOG-80 | TRIAMCINOLONE ACETONIDE | INJECTABLE;INJECTION | 80MG/ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N014901-001 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | |
| N014901-002 | KENALOG-80 | TRIAMCINOLONE ACETONIDE | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N014901-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-09-29 23:25 UTC | 2022-09 | N014901-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N014901-001 | AB | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N014901-001 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | 4ce116aa-b330-4da9-9cdd-ba8e6be0c4ad | 2026-01-05 | Warnings, Adverse reactions | 014901 NDA014901 50090-0819 |
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | d26b97b8-edc8-4b93-b6b9-429016208ff9 | 2025-12-05 | Warnings, Adverse reactions | 014901 NDA014901 50090-2360 |
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | E.R. Squibb & Sons, L.L.C. | cf970688-cd77-b95c-4bd9-c541590e9722 | 2024-08-20 | Warnings, Adverse reactions | 014901 NDA014901 0003-0293 0003-0315 |
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | cb0480b8-44ee-4506-b484-dc776c3092dc | 2023-06-15 | Warnings, Adverse reactions | 014901 NDA014901 50090-0256 |
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | Proficient Rx LP | 1ed85825-cd03-4b5b-9c9a-946653b5f71a | 2023-01-01 | Warnings, Adverse reactions | 014901 NDA014901 63187-661 |
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | Asclemed USA, Inc. | 0bc9c75f-963c-40b0-995b-dfcbd50371a5 | 2020-05-06 | Warnings, Adverse reactions | 014901 NDA014901 76420-085 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0003-0293 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0293 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0293 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0293 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0293 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0315 | KENALOG-80 | TRIAMCINOLONE ACETONIDE | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0315 | KENALOG-80 | TRIAMCINOLONE ACETONIDE | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0315 | KENALOG-80 | TRIAMCINOLONE ACETONIDE | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-0315 | KENALOG-80 | TRIAMCINOLONE ACETONIDE | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 21695-360 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | Rebel Distributors | NDA | Current |
| 49836-004 | P-Care K40MX | Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-004 | P-Care K40MX | Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-004 | P-Care K40MX | Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-005 | P-Care K40G | Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-005 | P-Care K40G | Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-005 | P-Care K40G | Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-006 | P-Care K40 | triamcinolone acetonide, povidone-iodine, isopropyl alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-006 | P-Care K40 | triamcinolone acetonide, povidone-iodine, isopropyl alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-006 | P-Care K40 | triamcinolone acetonide, povidone-iodine, isopropyl alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-007 | P-Care K80MX | Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-007 | P-Care K80MX | Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-007 | P-Care K80MX | Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-008 | P-Care K80 | Triamcinolone Acetonide, Povidone Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-008 | P-Care K80 | Triamcinolone Acetonide, Povidone Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-008 | P-Care K80 | Triamcinolone Acetonide, Povidone Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-009 | P-Care K80G | Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-009 | P-Care K80G | Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-009 | P-Care K80G | Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-524 | JTT Physicians | triamcinolone acetonide,lidocaine hydrochloride, povidone iodine, ammonia | RX PHARMA-PACK, INC. | NDA | Current |
| 49836-524 | JTT Physicians | triamcinolone acetonide,lidocaine hydrochloride, povidone iodine, ammonia | RX PHARMA-PACK, INC. | NDA | Current |
| 50090-0256 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | NDA | Current |
| 50090-0256 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | NDA | Current |
| 50090-0256 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | NDA | Current |
| 50090-0256 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | NDA | Current |
| 50090-0819 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | NDA | Current |
| 50090-0819 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | NDA | Current |
| 50090-0819 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | NDA | Current |
| 50090-2360 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | NDA | Current |
| 50090-2360 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | NDA | Current |
| 55045-3248 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | Dispensing Solutions, Inc. | NDA | Current |
| 63187-349 | Interarticular Joint Kit | AMMONIA, LIDOCAINE HYDROCHLORIDE ANHYDROUS, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINE | Proficient Rx LP | NDA | Current |
| 63187-661 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | Proficient Rx LP | NDA | Current |
| 63187-661 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | Proficient Rx LP | NDA | Current |
| 63187-661 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | Proficient Rx LP | NDA | Current |
| 69263-820 | Pro-C-Dure 5 Kit | kenalog | Oaklock, LLC | NDA | Current |
| 69263-820 | Pro-C-Dure 5 Kit | kenalog | Oaklock, LLC | NDA | Current |
| 69263-821 | Pro-C-Dure 6 Kit | kenalog | Oaklock, LLC | NDA | Current |
| 69263-821 | Pro-C-Dure 6 Kit | kenalog | Oaklock, LLC | NDA | Current |
| 69420-4001 | BT | bupivacaine hydrochloride, triamcinolone acetonide, povidone-iodine and isopropyl alcohol | SA3, LLC | NDA | Current |
| 69420-4002 | LT | lidocaine hydrochloride, triamcinolone acetonide, povidone-iodine and isopropyl alcohol | SA3, LLC | NDA | Current |
| 70518-0075 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | REMEDYREPACK INC. | NDA | Current |
| 70518-0075 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | REMEDYREPACK INC. | NDA | Current |
| 70518-0075 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | REMEDYREPACK INC. | NDA | Current |
| 76420-085 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | Asclemed USA, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80227 | SUPPL | 2024-11-18 |
| 80226 | SUPPL | 2024-11-18 |
| 78715 | SUPPL | 2024-06-07 |
| 78680 | SUPPL | 2024-06-06 |
| 63095 | SUPPL | 2020-05-19 |
| 63087 | SUPPL | 2020-05-19 |
| 54712 | SUPPL | 2018-06-28 |
| 53581 | SUPPL | 2018-04-01 |
| 53573 | SUPPL | 2018-04-01 |
| 48411 | SUPPL | 2017-05-17 |
| 10852 | SUPPL | 2014-07-09 |
| 391 | SUPPL | 2014-07-08 |
| 12075 | SUPPL | 2011-07-19 |
| 33128 | SUPPL | 2011-07-18 |
| 390 | SUPPL | 2011-06-17 |
| 33127 | SUPPL | 2011-06-16 |
| 12074 | SUPPL | 2010-02-05 |
| 10851 | SUPPL | 2010-02-04 |
| 40699 | SUPPL | 2009-01-12 |
| 40698 | SUPPL | 2009-01-12 |
| 40697 | SUPPL | 2009-01-12 |
| 20047 | SUPPL | 2009-01-12 |
| 20046 | SUPPL | 2009-01-12 |
| 389 | SUPPL | 2006-12-04 |
| 10850 | SUPPL | 2006-11-22 |