Application 021738
- Type
- NDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EXTINA | KETOCONAZOLE | AEROSOL, FOAM;TOPICAL | 2% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021738-001 | EXTINA | KETOCONAZOLE | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 |
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| 2026-08 | N021738-001 | EXTINA | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021738-001 | EXTINA | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021738-001 | EXTINA | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021738-001 | EXTINA | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021738-001 | EXTINA | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021738-001 | EXTINA | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021738-001 | EXTINA | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021738-001 | EXTINA | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AT | RLD, RS | 2007-06-12 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AT | RLD, RS | 2007-06-12 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AT | RLD, RS | 2007-06-12 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AT | RLD, RS | 2007-06-12 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AT | RLD, RS | 2007-06-12 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AT | RLD, RS | 2007-06-12 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AT | RLD, RS | 2007-06-12 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AT | RLD, RS | 2007-06-12 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | RLD | 2007-06-12 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N021738-001 | EXTINA | 2% | AEROSOL, FOAM / TOPICAL | AB | RLD, RS | 2007-06-12 | f41ea6bd6efb… |
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 | N021738-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021738-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021738-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021738-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021738-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021738-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021738-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021738-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021738-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021738-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021738-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021738-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021738-001 | AT | 1 | ea99ee380514… |
| 2024-02-18 07:12 UTC | 2024-02 | N021738-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021738-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021738-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021738-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021738-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021738-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021738-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021738-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021738-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N021738-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N021738-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021738-001 | 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 |
|---|---|---|---|---|---|---|
| Ketodan | KETOCONAZOLE | Medimetriks Pharmaceuticals, Inc. | 62f19bd8-926e-4e6b-9097-d81b894b95cc | 2024-12-05 | Warnings, Adverse reactions | KETOCONAZOLE |
| ketoconazole | KETOCONAZOLE | Bryant Ranch Prepack | 77989858-9f7a-45d6-97fb-deba1cba8fe8 | 2024-10-08 | Warnings, Adverse reactions | KETOCONAZOLE |
| ketoconazole | KETOCONAZOLE | Bryant Ranch Prepack | 513370d5-2e9f-4677-a0f2-63ff76142909 | 2024-10-08 | Warnings, Adverse reactions | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Bryant Ranch Prepack | d0fcab34-5451-456a-a75a-b1365d5dbc2c | 2024-06-20 | Adverse reactions | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Padagis Israel Pharmaceuticals Ltd | 99da5233-2760-46f6-8fb3-d9df5da70bfb | 2024-05-31 | Adverse reactions | KETOCONAZOLE |
| KETOCONAZOLE | KETOCONAZOLE | Bryant Ranch Prepack | 3ea8a22b-cd61-4623-a11f-43e3396b50fa | 2024-05-23 | Boxed warning, Warnings, Adverse reactions | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Bryant Ranch Prepack | b200ef76-5ea1-4253-bea5-1e8db0294510 | 2024-03-15 | Adverse reactions | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Viona Pharmaceuticals Inc | a4bb3f4c-ad93-4d85-b8d0-54eaa62228fd | 2024-03-11 | Adverse reactions | KETOCONAZOLE |
| ketoconazole | KETOCONAZOLE | Padagis Israel Pharmaceuticals Ltd | 9b65f632-a98d-400e-9ec3-84dea581d6a3 | 2024-02-29 | Warnings, Adverse reactions | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Bryant Ranch Prepack | 02a348b0-1325-4298-8813-83970da32c7a | 2024-01-11 | Warnings, Adverse reactions | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Bryant Ranch Prepack | dc635682-170d-46ad-a9ba-6a75c6e0950e | 2024-01-11 | Warnings, Adverse reactions | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | A-S Medication Solutions | b3b99c8b-4512-4972-935d-602d4b8325c4 | 2024-01-08 | Warnings, Adverse reactions | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | A-S Medication Solutions | 8ef1117d-0b63-4c26-beaa-7667b2387e14 | 2023-11-17 | Warnings, Adverse reactions | KETOCONAZOLE |
| KETOCONAZOLE | KETOCONAZOLE | A-S Medication Solutions | 517c29fc-2a2a-4bd5-a8bb-b464a65d2be0 | 2023-11-01 | Boxed warning, Warnings, Adverse reactions | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | A-S Medication Solutions | c29d4ddc-aa1c-41c6-99ce-9aff35d213f6 | 2023-09-25 | Adverse reactions | KETOCONAZOLE |
| KETOCONAZOLE | KETOCONAZOLE | Burel Pharmaceuticals, LLC | 57e81e13-b395-4dbd-b660-3038de41a838 | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Proficient Rx LP | cb1908da-443d-40b8-b8c7-b115bc2d37e0 | 2022-11-01 | Adverse reactions | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Proficient Rx LP | 4f08caf2-a57c-4146-9289-532711bbdbcd | 2022-04-01 | Warnings, Adverse reactions | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | Teva Pharmaceuticals USA, Inc. | 7fc47a6a-3714-4598-ae3b-d5a229262c21 | 2021-09-02 | Warnings, Adverse reactions | KETOCONAZOLE |
| Ketoconazole | KETOCONAZOLE | TOLMAR Inc. | 7036d1f2-c3f9-41d4-bc72-dd70e1691128 | 2020-06-03 | Adverse reactions | KETOCONAZOLE |
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 |
|---|---|---|---|---|---|
| 0378-7007 | Ketaconazole | Ketaconazole | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8136 | EXTINA | ketoconazole | Mylan Pharmaceuticals Inc. | NDA | Current |
| 40076-051 | EXTINA | ketoconazole | Prestium Pharma, Inc. | NDA | Current |