Application 083015
- Type
- ANDA
- Sponsor
- ASTELLAS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | ARISTOCORT | TRIAMCINOLONE ACETONIDE | CREAM;TOPICAL | 0.5% | No | No |
| 003 | ARISTOCORT A | TRIAMCINOLONE ACETONIDE | CREAM;TOPICAL | 0.5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A083015-002 | ARISTOCORT | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | ||
| A083015-003 | ARISTOCORT A | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A083015-002 | ARISTOCORT | 0.5% | CREAM / TOPICAL | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A083015-003 | ARISTOCORT A | 0.5% | CREAM / TOPICAL | Approved before 1982 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Direct_rx | 20ac5621-cd18-a7dd-e063-6394a90a99fa | 2026-03-17 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Asclemed USA, Inc. | b20c22b2-9a74-4b71-9015-40838fd2d193 | 2026-03-10 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | REMEDYREPACK INC. | e55f3f0f-bd52-47e4-b77d-73ede1b41466 | 2026-03-09 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | Direct_Rx | 93de78fb-1f19-cfc6-e053-2995a90a9bc7 | 2026-03-05 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Sagent Pharmaceuticals | 7dbee70b-bd11-4430-b626-97fbb8f01b49 | 2026-02-24 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | NuCare Pharmaceuticals,Inc. | bd45c7d2-a1a3-e0f5-e053-2a95a90ae4b3 | 2026-02-19 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | NuCare Pharmaceuticals,Inc. | bd465674-3527-1590-e053-2995a90a958d | 2026-02-19 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | 96f18791-480d-49f2-aac6-387321ae552c | 2026-02-14 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Amneal Pharmaceuticals LLC | c38dcd37-9840-4f71-a5c9-97380c8107f2 | 2026-02-12 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | 51fedf94-d94e-42b7-8e9f-e0e9b6bbd055 | 2026-02-11 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Sportpharm LLC | 4e0ddecf-7ea1-4f42-9924-53fe5a5657ff | 2026-02-10 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | ASCLEMED USA INC. | 1c6a740e-bc0d-41f3-b576-7d4c3880be23 | 2026-02-10 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | REMEDYREPACK INC. | c76d68dc-78e6-407c-ba9d-5d1c5d13509e | 2026-02-05 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | a5cc640f-c72d-49fa-b970-906c9ffd8629 | 2026-01-28 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 92a1ded0-8e1a-4994-9c8a-89e84fc85c94 | 2026-01-28 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | REMEDYREPACK INC. | d53c1728-6846-4e7d-a772-8b54ba9529b0 | 2026-01-26 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | ASCLEMED USA INC. | b909659e-8dd5-4652-89f4-c4d6b741a855 | 2026-01-23 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | NuCare Pharmaceuticals,Inc. | 5439cd3c-da8d-3b96-e054-00144ff8d46c | 2026-01-21 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | REMEDYREPACK INC. | 037efc03-22ab-45eb-9b0e-b125e4b5eb99 | 2026-01-20 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Sportpharm LLC | cab0573d-e760-4ff5-a69f-0ce06cfdb97a | 2026-01-19 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |