Application 083380
- Type
- ANDA
- Sponsor
- ASTELLAS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARISTOGEL | TRIAMCINOLONE ACETONIDE | GEL;TOPICAL | 0.1% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A083380-001 | ARISTOGEL | TRIAMCINOLONE ACETONIDE | 0.1% | GEL / TOPICAL | RLD, Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A083380-001 | ARISTOGEL | 0.1% | GEL / TOPICAL | Approved before 1982 | cb3db0bc1861… |
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-10 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | 653ec195-0966-478d-be47-6b1ff158e111 | 2026-07-30 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc. | 3d495acf-8085-4aaa-8fc5-594b88c25c21 | 2026-07-13 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Sportpharm LLC | 20c1234b-6749-422d-9420-9d5a98f5f30a | 2026-07-13 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | Ascend Laboratories, LLC | ccca8660-124e-4220-8d87-4b9aeecbda7d | 2026-07-13 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | Encube Ethicals, Inc. | db87426f-124c-4ea9-bb15-fc3a0da10a4e | 2026-07-07 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | Encube Ethicals, Inc. | 6a31a0c3-2b6e-40e3-b5ea-5c665afd3567 | 2026-07-06 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | 089a8449-7810-48ec-b327-494f058c3348 | 2026-06-22 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Amneal Pharmaceuticals LLC | 6b6eed06-ff96-4ceb-bb0c-a67a149987a4 | 2026-06-18 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Amneal Pharmaceuticals LLC | bf0b4d32-c8b7-48c9-a29b-3e7c2afc6cbf | 2026-06-17 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | NorthStar Rx LLC | 5f3aaf3a-cc66-4d4f-b9b7-2c50c325d477 | 2026-06-17 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| 24 Hour Nasal Allergy | TRIAMCINOLONE ACETONIDE | Meijer Distribution Inc | fcae02eb-454d-4752-8848-c0c590f1f529 | 2026-06-09 | Warnings | TRIAMCINOLONE ACETONIDE |
| Good Sense Nasal Allergy | TRIAMCINOLONE ACETONIDE | L. Perrigo Company | 082c79e9-d6b2-40b8-baf9-2a91b9ecaea4 | 2026-06-08 | Warnings | TRIAMCINOLONE ACETONIDE |
| TRIESENCE | TRIAMCINOLONE ACETONIDE | Harrow Eye, LLC | 2267978c-72ad-9229-e063-6394a90a09d0 | 2026-06-05 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | Bryant Ranch Prepack | b2ba93bc-3775-466b-8daf-4ffa3edc9c00 | 2026-05-28 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 444ca70e-fa06-4808-bd9d-d53ee725b752 | 2026-05-21 | Warnings | TRIAMCINOLONE ACETONIDE |
| Nasal Allergy | TRIAMCINOLONE ACETONIDE | Rugby Laboratories | 0ae25bc9-5d90-4dd8-9620-8684c4fd9d37 | 2026-05-21 | Warnings | TRIAMCINOLONE ACETONIDE |
| Triadermex | TRIAMCINOLONE ACETONIDE | Florrax Pharmaceutical | 3bda5cd1-df3c-4b4c-9868-cbc41f66f5a6 | 2026-05-21 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | Dr. Reddy's Laboratories Inc | af498d0a-c2a4-da25-3636-a1b45628e9e7 | 2026-05-20 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | Dr. Reddy's Labortories Inc | 8190195b-9847-d3d5-76a4-015cc24307e5 | 2026-05-20 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | REMEDYREPACK INC. | 484766b9-cec6-4379-b79d-398c921b32b2 | 2026-05-18 | Adverse reactions | TRIAMCINOLONE ACETONIDE |