Application 080750
- Type
- ANDA
- Sponsor
- ASTELLAS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 003 | ARISTOCORT A | TRIAMCINOLONE ACETONIDE | OINTMENT;TOPICAL | 0.1% | No | No |
| 004 | ARISTOCORT | TRIAMCINOLONE ACETONIDE | OINTMENT;TOPICAL | 0.1% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080750-003 | ARISTOCORT A | TRIAMCINOLONE ACETONIDE | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | ||
| A080750-004 | ARISTOCORT | TRIAMCINOLONE ACETONIDE | 0.1% | OINTMENT / 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080750-003 | ARISTOCORT A | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080750-004 | ARISTOCORT | 0.1% | OINTMENT / TOPICAL | Approved before 1982 | 74a2ff9319b5… |
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 | 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 |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc. | 60973042-077c-4265-988c-ad381f560333 | 2026-01-19 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Nasacort Allergy 24HR | TRIAMCINOLONE ACETONIDE | Chattem, Inc. | 4bff57a5-cce0-401c-a0fe-23c65c1b7ddc | 2026-01-14 | Warnings | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | 33793dfe-1214-4e0f-904c-771711ecb125 | 2026-01-14 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| TRIDERM | TRIAMCINOLONE ACETONIDE | Crown Laboratories | 2c7fee2c-6f57-4de4-8803-98c0b31b07c3 | 2026-01-12 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | REMEDYREPACK INC. | 570696d5-7c4e-4f89-b288-e3e09e3b32cc | 2026-01-09 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | 4ce116aa-b330-4da9-9cdd-ba8e6be0c4ad | 2026-01-05 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | RedpharmDrug | 2fc08cae-77e2-5e67-e063-6294a90aa593 | 2025-12-30 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| NASAL ALLERGY | TRIAMCINOLONE ACETONIDE | Safeway | fe41d6c4-f1f4-4fec-adbc-85df460fdfc3 | 2025-12-06 | Warnings | TRIAMCINOLONE ACETONIDE |
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | d26b97b8-edc8-4b93-b6b9-429016208ff9 | 2025-12-05 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | fab09252-d474-4894-bbbf-a95b14c78936 | 2025-11-26 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| KOURZEQ | TRIAMCINOLONE ACETONIDE | MidAmerica Pharmaceuticals | aad48d1e-f8db-4020-92af-0b3258bbc0f2 | 2025-11-18 | Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Alembic Pharmaceuticals Inc. | 05c2a9cf-a018-48c0-9c73-2d59d52211d2 | 2025-11-03 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Alembic Pharmaceuticals Limited | c0b487dd-a47b-42fd-a855-5d237c5651a9 | 2025-11-03 | Warnings, Adverse reactions | TRIAMCINOLONE ACETONIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.