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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080443-002 | NUTRACORT | 0.5% | LOTION / TOPICAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080443-003 | NUTRACORT | 1% | LOTION / TOPICAL | Approved before 1982 | caaa826d4ba7… | ||
| 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… |
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 | PD-Rx Pharmaceuticals, Inc. | 931ed426-89a1-4877-a4a5-cb963d51e717 | 2026-02-25 | Warnings, Adverse reactions | HYDROCORTISONE |
| Hydrocortisone | HYDROCORTISONE | A-S Medication Solutions | a3fbdae4-d1dc-42de-939f-f9a7aab60e49 | 2026-02-24 | Adverse reactions | HYDROCORTISONE |
| Hydrocortisone | HYDROCORTISONE | Sportpharm LLC | 9578b39e-3df7-4d75-abd7-f1d5524545e5 | 2026-02-23 | Warnings | HYDROCORTISONE |
| Hydrocortisone | HYDROCORTISONE | A-S Medication Solutions | bb959c6f-7c9a-43c5-a45b-2ad9a87baa88 | 2026-02-18 | Adverse reactions | HYDROCORTISONE |
| Hydrocortisone | HYDROCORTISONE | Medrock Pharmacy LLC | 43e00e17-1a48-43db-9589-834568917bbf | 2026-02-17 | Warnings | HYDROCORTISONE |
| Natureplex Hydrocortisone Hydro | HYDROCORTISONE | Natureplex, LLC | 2fc6a148-34bb-4289-8588-32c1bb011b98 | 2026-02-13 | Warnings | HYDROCORTISONE |
| Aquanil HC | HYDROCORTISONE | Person and Covey | 4a698246-05a6-d01f-e063-6294a90a3401 | 2026-02-09 | Warnings | HYDROCORTISONE |
| hydrocortisone | HYDROCORTISONE | Sportpharm LLC | ee64ad1e-78db-4553-a3cf-b539b770fa26 | 2026-02-06 | Warnings | HYDROCORTISONE |
| HYDROCORTISONE | HYDROCORTISONE | CVS PHARMACY, INC | 8b8cdb26-8e8f-4e95-9d83-d685c90afe01 | 2026-02-02 | Warnings | HYDROCORTISONE |
| Hydrocortisone | HYDROCORTISONE | A-S Medication Solutions | 5c4c3e02-5272-4a28-a9c8-1c5fa3ae181c | 2026-01-30 | Adverse reactions | HYDROCORTISONE |
| ProCure Hydrocortisone Cream Plus | HYDROCORTISONE | Rooftop Consumer Health, Inc. | fe334cae-e019-4397-8498-df3c923ae8b5 | 2026-01-29 | Warnings | HYDROCORTISONE |
| hydrocortisone | HYDROCORTISONE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | bc374fa4-ac8b-408e-9321-8bab97a18770 | 2026-01-28 | Adverse reactions | HYDROCORTISONE |
| Hydrocortisone | HYDROCORTISONE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 31fbb576-0e76-471c-83c8-9e0125bc1791 | 2026-01-28 | Adverse reactions | HYDROCORTISONE |
| Hydrocortisone | HYDROCORTISONE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | bcd103f3-3dc8-4394-b8fd-8f8ddb721f77 | 2026-01-28 | Adverse reactions | HYDROCORTISONE |
| Hydrocortisone with Aloe | HYDROCORTISONE | STRATEGIC SOURCING SERVICES LLC | 4a113699-1eb7-49b8-8cdf-2ad57db89b81 | 2026-01-27 | Warnings | HYDROCORTISONE |
| Viaderma Calm Anti-Itch | HYDROCORTISONE | VIADERMA DISTRIBUTION INC | ea281bde-a7a2-47b6-895a-5dc2924972de | 2026-01-27 | Warnings | HYDROCORTISONE |
| Rapidol | HYDROCORTISONE | Pharmadel LLC | 19a1f1e2-bc6b-7153-e063-6294a90ab115 | 2026-01-23 | Warnings | HYDROCORTISONE |
| Aveeno 1% Hydrocortisone Anti-Itch Cream | HYDROCORTISONE | Kenvue Brands LLC | 1ac0ac4e-af76-9a3e-e063-6394a90a1269 | 2026-01-22 | Warnings | HYDROCORTISONE |
| Anti Itch | HYDROCORTISONE | HyVee Inc | ae31f1f5-db70-45cf-850e-67bfe6860748 | 2026-01-21 | Warnings | HYDROCORTISONE |
| Skin Relief Cream | HYDROCORTISONE | Spa de Soleil | 0a90b77a-4be4-71c5-e063-6294a90a8e41 | 2026-01-20 | Warnings | HYDROCORTISONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.