Application 209595
- Type
- ANDA
- Sponsor
- COSETTE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DESOXIMETASONE | DESOXIMETASONE | CREAM;TOPICAL | 0.25% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209595-001 | DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 |
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 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | AB | 2020-03-04 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209595-001 | DESOXIMETASONE | 0.25% | CREAM / TOPICAL | 2020-03-04 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209595-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A209595-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A209595-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A209595-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A209595-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209595-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A209595-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A209595-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A209595-001 | AB | 1 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209595-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A209595-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A209595-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209595-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209595-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209595-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209595-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A209595-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A209595-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209595-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A209595-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A209595-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209595-001 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| desoximetasone | DESOXIMETASONE | Zydus Lifesciences Limited | 959e396a-2458-43b5-b412-db1974d58d8d | 2024-08-14 | desoximetasone DESOXIMETASONE | |
| desoximetasone | DESOXIMETASONE | Bryant Ranch Prepack | 155e0a5f-183b-4517-88e3-22fef48d72c8 | 2024-05-31 | Warnings, Adverse reactions | desoximetasone DESOXIMETASONE |
| desoximetasone | DESOXIMETASONE | Bryant Ranch Prepack | 23b53d98-71fe-4e64-b546-9d7c8ec21a6c | 2024-04-04 | Warnings, Adverse reactions | desoximetasone DESOXIMETASONE |
| desoximetasone | DESOXIMETASONE | Bryant Ranch Prepack | 2a59a313-efd8-4377-bd41-caeeffa79775 | 2024-03-12 | Warnings, Adverse reactions | desoximetasone DESOXIMETASONE |
| Desoximetasone | DESOXIMETASONE | A-S Medication Solutions | 0e72952e-8e9f-467a-8191-2bc157087d60 | 2023-12-09 | Warnings, Adverse reactions | Desoximetasone DESOXIMETASONE |
| desoximetasone | DESOXIMETASONE | Padagis Israel Pharmaceuticals Ltd | dc104fb8-4d7c-4bed-b2d8-8d9cfe8f0e5b | 2023-08-31 | Warnings, Adverse reactions | desoximetasone DESOXIMETASONE |
| desoximetasone | DESOXIMETASONE | Bryant Ranch Prepack | dbaa172e-2f78-4c14-9abc-cc171b75115d | 2023-07-17 | Warnings, Adverse reactions | desoximetasone DESOXIMETASONE |
| desoximetasone | DESOXIMETASONE | Padagis Israel Pharmaceuticals Ltd | 4025ed23-a591-4754-8dbb-4da18f49a3e3 | 2022-12-02 | Warnings, Adverse reactions | desoximetasone DESOXIMETASONE |
| desoximetasone | DESOXIMETASONE | Viona Pharmaceuticals Inc | f8e213a9-5e80-45e2-834c-7734dd39c1ac | 2022-10-04 | Warnings, Adverse reactions | desoximetasone DESOXIMETASONE |
| desoximetasone | DESOXIMETASONE | Viona Pharmaceuticals Inc | 309a93de-ce89-4244-959a-3236d5e95c06 | 2022-10-04 | Warnings, Adverse reactions | desoximetasone DESOXIMETASONE |
| Desoximetasone | DESOXIMETASONE | Proficient Rx LP | f30b6fcc-43bc-4d65-9c3b-8d6ca780a024 | 2022-04-01 | Warnings, Adverse reactions | Desoximetasone DESOXIMETASONE |
| Desoximetasone | DESOXIMETASONE | Proficient Rx LP | 4f90b0cd-9443-4940-8781-1a05e42ccbb8 | 2020-06-01 | Warnings, Adverse reactions | Desoximetasone DESOXIMETASONE |
| Desoximetasone | DESOXIMETASONE | Actavis Pharma, Inc. | c342beac-547b-4b0b-a39c-44a0961f924b | 2020-01-01 | Warnings, Adverse reactions | Desoximetasone DESOXIMETASONE |
| Desoximetasone | DESOXIMETASONE | Glenmark Pharmaceuticals Inc., USA | ea742af6-9359-46c3-9164-ab53e8c1461e | 2018-12-11 | Warnings, Adverse reactions | Desoximetasone DESOXIMETASONE |
| Desoximetasone | DESOXIMETASONE | Novel Laboratories, Inc. | 781a7bba-b00d-4ceb-aefe-74c73d263b67 | 2016-06-01 | Warnings, Adverse reactions | Desoximetasone DESOXIMETASONE |
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 |
|---|---|---|---|---|---|
| 0713-0674 | Desoximetasone | Desoximetasone | Cosette Pharmaceuticals, Inc. | ANDA | Current |