Application 215185
- Type
- ANDA
- Sponsor
- TASMAN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KETOCONAZOLE | KETOCONAZOLE | CREAM;TOPICAL | 2% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215185-001 | KETOCONAZOLE | KETOCONAZOLE | 2% | CREAM / TOPICAL | 2021-11-17 |
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 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | 2021-11-17 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | 2021-11-17 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | 2021-11-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | AB | 2021-11-17 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215185-001 | KETOCONAZOLE | 2% | CREAM / TOPICAL | 2021-11-17 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215185-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A215185-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215185-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215185-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215185-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215185-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215185-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215185-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A215185-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215185-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215185-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215185-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A215185-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A215185-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A215185-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A215185-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A215185-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A215185-001 | AB | 1 | 782e0a99824c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215185-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A215185-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A215185-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215185-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215185-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215185-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215185-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A215185-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A215185-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A215185-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A215185-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A215185-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A215185-001 | 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 |
|---|---|---|---|---|---|---|
| KETOCONAZOLE | KETOCONAZOLE | Strides Pharma Science Limited | 6d4be760-c723-4f54-a854-12c61cf91703 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | KETOCONAZOLE KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | NuCare Pharmaceuticals,Inc. | 4578c84a-d438-6740-e063-6294a90a0151 | 2025-12-08 | Adverse reactions | Ketoconazole KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Northstar Rx LLC | c4f711dc-d0ea-4beb-9a78-b7e3594ee4be | 2025-12-01 | Adverse reactions | Ketoconazole KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Bryant Ranch Prepack | 4baebcab-a237-42c0-9183-6f447a44e371 | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | Ketoconazole KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Golden State Medical Supply, Inc. | a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7 | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | Ketoconazole KETOCONAZOLE |
| ketoconazole | KETOCONAZOLE | Bryant Ranch Prepack | a878a39d-6d26-4ede-9667-b3e201ffc337 | 2025-10-24 | Warnings, Adverse reactions | ketoconazole KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Bryant Ranch Prepack | 6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf | 2025-10-24 | Adverse reactions | Ketoconazole KETOCONAZOLE |
| ketoconazole | KETOCONAZOLE | Bryant Ranch Prepack | 65dd4435-99f2-4383-b307-ba5bce9f1ca9 | 2025-10-24 | Warnings, Adverse reactions | ketoconazole KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE CREAM, 2% | Encube Ethicals, Inc. | 59188ef7-5bc9-4acc-bbff-8712c41e5f77 | 2025-09-09 | Warnings, Adverse reactions | Ketoconazole |
| Ketoconazole | KETOCONAZOLE | Sun Pharmaceutical Industries, Inc. | 8ca815a8-bccb-4ee2-a042-922373329cae | 2025-09-02 | Boxed warning, Warnings, Adverse reactions | Ketoconazole KETOCONAZOLE |
| Nizoral | KETOCONAZOLE | Kramer Laboratories | f5c8c5b4-49bd-4dc7-8c29-8f1317c6ef88 | 2025-08-21 | Warnings | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE CREAM, 2% | A-S Medication Solutions | 750bcfc3-b0e4-407e-ad12-e81b183f3b00 | 2025-07-23 | Warnings, Adverse reactions | Ketoconazole |
| Nizoral | KETOCONAZOLE | Kramer Laboratories | 8dd6b2f1-f438-4be1-a6c4-4f6c8902dfb6 | 2025-07-11 | Warnings | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Golden State Medical Supply, Inc. | 3e3cde4b-939f-4837-9920-bb6bb8416bd6 | 2025-07-10 | Warnings, Adverse reactions | Ketoconazole KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Sun Pharmaceutical Industries, Inc. | 39b85d6a-9133-42e6-b7f8-58f045e9b9f0 | 2025-07-07 | Warnings, Adverse reactions | Ketoconazole KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Amici Pharma Inc. | 369f31da-d3c3-49b8-956f-f70598760164 | 2025-06-21 | Boxed warning, Warnings, Adverse reactions | Ketoconazole KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Preferred Pharmaceuticals Inc. | 39d31bed-9caa-41bb-afdb-25fc18609c14 | 2025-04-24 | Adverse reactions | Ketoconazole KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | A-S Medication Solutions | a884bad7-df8c-45de-8c4f-42034b40e425 | 2025-04-23 | Adverse reactions | Ketoconazole KETOCONAZOLE |
| Tagrit Antifungal Treament Ketoconazole 1% | KETOCONAZOLE | TAGRID LLC | 315a8832-c42f-c07a-e063-6394a90a8218 | 2025-03-27 | Warnings | KETOCONAZOLE |
| 1% ketoconazole | KETOCONAZOLE | TAGRID LLC | 30b75584-3a1e-c125-e063-6294a90acaa7 | 2025-03-19 | Warnings | KETOCONAZOLE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.