Application 080443
- Type
- ANDA
- Sponsor
- DOW PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | NUTRACORT | HYDROCORTISONE | LOTION;TOPICAL | 0.5% | No | No |
| 003 | NUTRACORT | HYDROCORTISONE | LOTION;TOPICAL | 1% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080443-002 | NUTRACORT | HYDROCORTISONE | 0.5% | LOTION / TOPICAL | Approved before 1982 | ||
| A080443-003 | NUTRACORT | HYDROCORTISONE | 1% | LOTION / 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 9f64ed9d-64c8-48e9-ac54-1aa9b26a6060 | 2026-04-03 | Adverse reactions | HYDROCORTISONE |
| FifthPulse Hydrocortisone | HYDROCORTISONE | WeCare Products LLC | f1fcb045-4a15-431b-9617-67eae9f87fbd | 2026-04-02 | Warnings | HYDROCORTISONE |
| Hydroxym | HYDROCORTISONE | Oncora Pharma, LLC | a161b69c-df9d-4827-ace8-f622aca9efc3 | 2026-04-02 | Warnings, Adverse reactions | HYDROCORTISONE |
| Khindivi | HYDROCORTISONE | Eton Pharmaceuticals, Inc. | 1ef80500-8386-40ee-b608-516cd687b376 | 2026-04-01 | Warnings, Adverse reactions | HYDROCORTISONE |
| Hydrocortisone | HYDROCORTISONE | Redmont Pharmaceuticals, LLC | fb2f9fa2-5feb-4398-a21b-15a3137ac3bd | 2026-03-31 | Warnings, Adverse reactions | HYDROCORTISONE |
| Hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 5e95eb82-40cd-411b-9006-c27b65db4b3f | 2026-03-25 | Adverse reactions | HYDROCORTISONE |
| Hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 7f262fa3-4d2a-43f2-a4a7-f49f6034cf50 | 2026-03-25 | Adverse reactions | HYDROCORTISONE |
| Hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 3d17e73a-15f5-4881-baf2-47a0149585fd | 2026-03-25 | Adverse reactions | HYDROCORTISONE |
| Hydrocortisone 1% | HYDROCORTISONE | ProStat First Aid | 4e53d29c-ed3c-f481-e063-6294a90a3181 | 2026-03-25 | Warnings | HYDROCORTISONE |
| BARMICIL PLUS | HYDROCORTISONE | OPMX LLC | fb5f4743-61e8-46c8-8561-38e17aeaa4d5 | 2026-03-24 | Warnings | HYDROCORTISONE |
| Barmicil Anti-itch | HYDROCORTISONE | OPMX LLC | 850084c3-1dd4-eb8d-e053-2a91aa0a130b | 2026-03-24 | Warnings | HYDROCORTISONE |
| hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 99726aa3-3b45-4175-8471-279419af5457 | 2026-03-18 | Warnings | HYDROCORTISONE |
| Hydrocortisone | HYDROCORTISONE | Mericon Industries | 8f351b04-8f6d-4353-9100-13a8a80d656a | 2026-03-17 | Warnings | HYDROCORTISONE |
| Crane Safety Hydrocortisone | HYDROCORTISONE | Crane Safety LLC | 96d9527d-9bf7-ce82-e053-2995a90aff0c | 2026-03-16 | Warnings | HYDROCORTISONE |
| Hydrocortisone 1% | HYDROCORTISONE | ProStat First Aid | 4cd62cba-075a-7448-e063-6394a90ab48d | 2026-03-12 | Warnings | HYDROCORTISONE |
| Hydrocortisone | HYDROCORTISONE | Strides Pharma Science Limited | 90a46849-5b75-467b-9bc5-8f192d4d20d2 | 2026-03-11 | Warnings, Adverse reactions | HYDROCORTISONE |
| HYDROCORTISONE | HYDROCORTISONE | DIRECT RX | 3d017594-3a00-40ba-b392-1699992fa1b1 | 2026-03-05 | Adverse reactions | HYDROCORTISONE |
| Hydrocortisone 1% | HYDROCORTISONE | Trifecta Pharmaceuticals Usa Llc | f4d4a56b-b4b7-9a07-e053-2a95a90ad853 | 2026-03-04 | Warnings | HYDROCORTISONE |
| Hydrocortisone 1% | HYDROCORTISONE | Trifecta Pharmaceuticals Usa Llc | 9987165c-1a0f-dd57-e053-2a95a90ae735 | 2026-03-04 | Warnings | HYDROCORTISONE |
| Cortenema | HYDROCORTISONE | ANI Pharmaceuticals, Inc. | a307448a-ccc4-41a8-977a-11f28f0bded9 | 2026-03-02 | Warnings, Adverse reactions | HYDROCORTISONE |