Application 018751
- Type
- NDA
- Sponsor
- ALVOGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SPECTAZOLE | ECONAZOLE NITRATE | CREAM;TOPICAL | 1% | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018751-001 | SPECTAZOLE | ECONAZOLE NITRATE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | AB | RLD | 1982-12-23 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | AB | RLD | 1982-12-23 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | AB | RLD | 1982-12-23 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | AB | RLD | 1982-12-23 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | AB | RLD | 1982-12-23 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | AB | RLD | 1982-12-23 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | AB | RLD | 1982-12-23 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | AB | RLD | 1982-12-23 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | AB | RLD | 1982-12-23 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | AB | RLD | 1982-12-23 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | AB | RLD | 1982-12-23 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | AB | RLD | 1982-12-23 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | AB | RLD | 1982-12-23 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018751-001 | SPECTAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD | 1982-12-23 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | RLD | 1982-12-23 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | RLD | 1982-12-23 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | RLD | 1982-12-23 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | RLD | 1982-12-23 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N018751-001 | SPECTAZOLE | 1% | CREAM / TOPICAL | RLD | 1982-12-23 | e64feba35796… |
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 | N018751-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N018751-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N018751-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N018751-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N018751-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N018751-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018751-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N018751-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N018751-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N018751-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N018751-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N018751-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N018751-001 | AB | 1 | ea99ee380514… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018751-001 | 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 |
|---|---|---|---|---|---|---|
| Econazole Nitrate | ECONAZOLE NITRATE | Encube Ethicals, Inc. | 64d82b8b-d749-4bfe-ba3e-25836d54e115 | 2026-06-22 | Warnings, Adverse reactions | ECONAZOLE NITRATE |
| Econazole Nitrate | ECONAZOLE NITRATE | Bryant Ranch Prepack | 790a86cc-e93b-4bb6-9b60-08b2c4587081 | 2026-06-12 | Warnings, Adverse reactions | ECONAZOLE NITRATE |
| ECONAZOLE NITRATE | ECONAZOLE NITRATE | Aurobindo Pharma Limited | 74e5bbc9-eaea-405e-b64b-b3527c5ea084 | 2026-05-12 | Warnings, Adverse reactions | ECONAZOLE NITRATE |
| Econazole Nitrate | ECONAZOLE NITRATE | Preferred Pharmaceuticals Inc. | 6989d30f-9bb7-4e6e-92de-05e9f9a4f523 | 2026-04-10 | Warnings, Adverse reactions | ECONAZOLE NITRATE |
| Econazole Nitrate | ECONAZOLE NITRATE | Preferred Pharmaceuticals Inc. | caa348ad-4832-435f-844d-55831f235cc0 | 2026-04-09 | Warnings, Adverse reactions | ECONAZOLE NITRATE |
| Econazole Nitrate | ECONAZOLE NITRATE | Trifluent Pharma, LLC | 3eb40c94-f369-ce4b-e063-6294a90abed4 | 2025-10-31 | Warnings, Adverse reactions | ECONAZOLE NITRATE |
| Econazole Nitrate | ECONAZOLE NITRATE | Sun Pharmaceutical Industries, Inc. | 90c40d7f-94fa-440c-9815-30378f76ae79 | 2025-08-26 | Warnings, Adverse reactions | ECONAZOLE NITRATE |
| Econazole Nitrate | ECONAZOLE NITRATE | Preferred Pharmaceuticals Inc. | 2bd2a48e-cbef-4b14-a02f-9aa693cc4b47 | 2025-06-02 | Warnings, Adverse reactions | ECONAZOLE NITRATE |
| Econazole Nitrate | ECONAZOLE NITRATE | Bryant Ranch Prepack | b0c90efd-d9a2-4120-aa17-33a9d50f7347 | 2025-01-29 | Warnings, Adverse reactions | ECONAZOLE NITRATE |
| Econazole Nitrate | ECONAZOLE NITRATE | Bryant Ranch Prepack | ae173340-7611-4dc8-99a7-7669bc4fc97d | 2024-04-04 | Warnings, Adverse reactions | ECONAZOLE NITRATE |
| Econazole Nitrate | ECONAZOLE NITRATE | Bryant Ranch Prepack | 4ac65707-a8b2-45de-a3c6-89e3ea845124 | 2024-01-11 | Warnings, Adverse reactions | ECONAZOLE NITRATE |
| Ecoza | ECONAZOLE NITRATE | Resilia Pharmaceuticals, Inc. | 0bb5fa27-32ed-ed13-e063-6394a90a1577 | 2023-12-04 | Warnings, Adverse reactions | ECONAZOLE NITRATE |
| Econazole Nitrate | ECONAZOLE NITRATE | Padagis Israel Pharmaceuticals Ltd | 3acc5e03-0339-4b23-945d-641746e81923 | 2023-11-30 | Warnings, Adverse reactions | ECONAZOLE NITRATE |