Application 016908
- Type
- NDA
- Sponsor
- CNTY LINE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | LIDEX | FLUOCINONIDE | CREAM;TOPICAL | 0.05% | Yes | No |
| 003 | LIDEX-E | FLUOCINONIDE | CREAM;TOPICAL | 0.05% | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N016908-002 | LIDEX | FLUOCINONIDE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | ||
| N016908-003 | LIDEX-E | FLUOCINONIDE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 |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| 2026-08 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N016908-002 | LIDEX | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N016908-002 | LIDEX | 0.05% | CREAM / TOPICAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / TOPICAL | AB2 | RLD, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N016908-002 | LIDEX | 0.05% | CREAM / TOPICAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N016908-003 | LIDEX-E | 0.05% | CREAM / TOPICAL | AB2 | RLD, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N016908-002 | LIDEX | 0.05% | CREAM / TOPICAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N016908-003 | LIDEX-E | 0.05% | CREAM / TOPICAL | AB2 | RLD, Approved before 1982 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N016908-002 | LIDEX | 0.05% | CREAM / TOPICAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N016908-003 | LIDEX-E | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM / TOPICAL | AB2 | RLD, Approved before 1982 | 74a2ff9319b5… |
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 | N016908-003 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N016908-003 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N016908-003 | AB2 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N016908-003 | AB2 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N016908-003 | AB2 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N016908-003 | AB2 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N016908-003 | AB2 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N016908-003 | AB2 | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N016908-003 | AB2 | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N016908-003 | AB2 | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N016908-003 | AB2 | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N016908-003 | AB2 | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N016908-003 | AB2 | 1 | ea99ee380514… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N016908-003 | AB2 | 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 |
|---|---|---|---|---|---|---|
| Fluocinonide | FLUOCINONIDE | Teva Pharmaceuticals USA, Inc. | 986c1ba3-2103-4773-a35c-2c0121a01783 | 2024-09-30 | Adverse reactions | FLUOCINONIDE |
| FLUOCINONIDE | FLUOCINONIDE | Zydus Lifesciences Limited | 08d69d3f-c628-4b08-a7ae-0f7ec5599d3a | 2024-08-16 | FLUOCINONIDE | |
| Fluocinonide | FLUOCINONIDE | NuCare Pharmaceuticals, Inc. | 51cbe73c-e5d6-1e6a-e054-00144ff88e88 | 2024-08-14 | Adverse reactions | FLUOCINONIDE |
| Fluocinonide | FLUOCINONIDE | NuCare Pharmaceuticals,Inc. | a8eefd01-340e-5eef-e053-2a95a90a802c | 2024-07-17 | Adverse reactions | FLUOCINONIDE |
| Fluocinonide | FLUOCINONIDE | NuCare Pharmaceuticals,Inc. | 8ac0ecd6-38b5-a5f9-e053-2a95a90af412 | 2024-06-14 | Adverse reactions | FLUOCINONIDE |
| Fluocinonide | FLUOCINONIDE | NuCare Pharmaceuticals Inc. | 624c81a7-282a-95be-e053-2991aa0a6b44 | 2024-06-06 | Adverse reactions | FLUOCINONIDE |
| FLUOCINONIDE | FLUOCINONIDE | Bryant Ranch Prepack | 3e549888-f5f9-41da-b30d-a499da852282 | 2024-02-02 | Warnings, Adverse reactions | FLUOCINONIDE |
| Fluocinonide | FLUOCINONIDE | Bryant Ranch Prepack | 4fbb3f39-c856-4da6-90b1-a6749de892c5 | 2024-01-10 | Adverse reactions | FLUOCINONIDE |
| Fluocinonide | FLUOCINONIDE | Bryant Ranch Prepack | 9ee44ed9-e274-4673-8829-0032a36e5b79 | 2024-01-10 | Adverse reactions | FLUOCINONIDE |
| Fluocinonide | FLUOCINONIDE | Bryant Ranch Prepack | 0a1dab63-17d0-4ae7-890b-7746be65e29b | 2024-01-10 | Adverse reactions | FLUOCINONIDE |
| Fluocinonide | FLUOCINONIDE | Asclemed USA, Inc. | cd5d8268-77ff-41c0-8699-b583e52da30c | 2023-12-16 | Boxed warning, Warnings, Adverse reactions | FLUOCINONIDE |
| Fluocinonide | FLUOCINONIDE | Cosette Pharmaceuticals, Inc. | b28c444d-cb70-42c3-a437-c66ae961dbb4 | 2023-11-22 | Adverse reactions | FLUOCINONIDE |
| Fluocinonide Cream | FLUOCINONIDE | Amneal Pharmaceuticals NY LLC | 817cac6b-fec5-406d-aa0c-8852d08a3c65 | 2023-06-06 | Adverse reactions | FLUOCINONIDE |
| FLUOCINONIDE | FLUOCINONIDE | Bryant Ranch Prepack | 7055d0d3-b148-4ab3-b423-9fc417204b0a | 2023-03-03 | Warnings, Adverse reactions | FLUOCINONIDE |
| FLUOCINONIDE | FLUOCINONIDE | Bryant Ranch Prepack | 50d06efd-9caa-4254-bf1f-eb430c5178b0 | 2023-03-03 | Warnings, Adverse reactions | FLUOCINONIDE |
| FLUOCINONIDE | FLUOCINONIDE | Bryant Ranch Prepack | 34b5a550-4152-4f77-bc07-e4f023fca568 | 2023-03-03 | Warnings, Adverse reactions | FLUOCINONIDE |
| Fluocinonide | FLUOCINONIDE | Macleods Pharmaceuticals Limited | a439ac59-42f3-412b-b987-14fc152a974f | 2023-01-27 | Adverse reactions | FLUOCINONIDE |
| Fluocinol Pak | FLUOCINONIDE | PureTek Corporation | a9c88a41-3ff8-78f7-e053-2995a90adb8f | 2023-01-11 | Warnings, Adverse reactions | FLUOCINONIDE |
| Fluocinonide | FLUOCINONIDE | Cosette Pharmaceuticals, Inc. | e3348b90-8c16-4788-ab61-e354aea5d0a8 | 2022-12-27 | Adverse reactions | FLUOCINONIDE |
| Fluocinonide | FLUOCINONIDE | Asclemed USA, Inc. | b387f926-1109-41b2-9fe0-f77db6b10280 | 2022-12-13 | Warnings, Adverse reactions | FLUOCINONIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
Documents#
| Document | Submission type | Date |
|---|---|---|
| 515 | SUPPL | 2006-01-19 |