Application 088818
- Type
- ANDA
- Sponsor
- ASTELLAS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARISTOCORT A | TRIAMCINOLONE ACETONIDE | CREAM;TOPICAL | 0.025% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A088818-001 | ARISTOCORT A | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | 1984-10-16 |
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 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A088818-001 | ARISTOCORT A | 0.025% | CREAM / TOPICAL | 1984-10-16 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| NASAL ALLERGY RELIEF | TRIAMCINOLONE ACETONIDE | Kroger Company | 47d05350-26a8-4348-b506-078e0984fa87 | 2025-10-27 | Warnings | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Long Grove Pharmaceuticals, LLC | 9e48eec7-7cd5-4174-8b3f-07c96f4ef115 | 2025-10-22 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Sun Pharmaceutical Industries, Inc. | e7e16fc2-0222-44f5-925b-928d249f55cf | 2025-10-15 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | f65c5847-365e-44b0-a756-1b16788684db | 2025-10-09 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Xipere | TRIAMCINOLONE ACETONIDE | Bausch & Lomb Incorporated | ea6ad429-967f-4f75-a33d-e06f849bee80 | 2025-10-08 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc. | 5701a07f-bd22-4bc7-95ff-0c5444ea5971 | 2025-10-01 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc | 2548307e-8d36-4a63-862b-f2af7856104e | 2025-10-01 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc | adc16c6b-b508-48b8-af8c-a5f03f2955fe | 2025-10-01 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals, Inc. | a1633e66-2ce8-42e4-8046-ac10dadfa34b | 2025-10-01 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc. | 777c3cb9-da2b-431c-934f-f3c70f93d6cb | 2025-10-01 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc. | 99f8a0e6-8ee8-4430-b1d5-1022da1d72ab | 2025-10-01 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Sun Pharmaceutical Industries, Inc. | b353c8b1-9088-4969-8199-37876f2461cc | 2025-09-15 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | ProPharma Distribution | 3edd3ad8-2561-59b5-e063-6294a90a0165 | 2025-09-15 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | Allegiant Health | 1fd76a49-61ee-4d4d-8abc-e666b2d3c5b0 | 2025-07-29 | Warnings | TRIAMCINOLONE ACETONIDE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | Bryant Ranch Prepack | d870041e-7c92-4f88-a305-ecb8f50a5773 | 2025-07-28 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | Bryant Ranch Prepack | d086c38e-99c7-4d25-a722-a61c77d3989b | 2025-07-28 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | QUAGEN PHARMACEUTICALS LLC | 4c6ff738-60a3-4339-8e94-26fb9df65841 | 2025-07-22 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc. | d0428b54-c4f5-46f1-a65e-7e20c56dbe78 | 2025-07-10 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Oralone | TRIAMCINOLONE ACETONIDE | Sun Pharmaceutical Industries, Inc. | ac1e2116-795e-4c20-974d-11fa07cf0fa7 | 2025-07-07 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Sun Pharmaceutical Industries, Inc. | 6b4a9a08-f436-4f33-a940-a97c727788f9 | 2025-07-03 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.