Application 013790
- Type
- NDA
- Sponsor
- ALMIRALL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CORDRAN | FLURANDRENOLIDE | LOTION;TOPICAL | 0.05% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N013790-001 | CORDRAN | FLURANDRENOLIDE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | RLD, Approved before 1982 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N013790-001 | CORDRAN | 0.05% | LOTION / TOPICAL | AT | RLD, RS, Approved before 1982 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N013790-001 | CORDRAN | 0.05% | LOTION / TOPICAL | AT | RLD, RS, Approved before 1982 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N013790-001 | CORDRAN | 0.05% | LOTION / TOPICAL | AT | RLD, RS, Approved before 1982 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N013790-001 | CORDRAN | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION / TOPICAL | RLD, Approved before 1982 | a50c72e98297… |
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 | N013790-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N013790-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N013790-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N013790-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N013790-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N013790-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N013790-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N013790-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N013790-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N013790-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N013790-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N013790-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N013790-001 | AT | 1 | ea99ee380514… |
| 2023-05-13 08:27 UTC | 2023-05 | N013790-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N013790-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N013790-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N013790-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N013790-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N013790-001 | AT | 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 |
|---|---|---|---|---|---|---|
| CORDRAN | FLURANDRENOLIDE | INA Pharmaceutics, Inc | 39c0d1e6-6816-7ae5-e063-6394a90a592e | 2025-07-07 | Adverse reactions | CORDRAN FLURANDRENOLIDE |
| CORDRAN | FLURANDRENOLIDE | Almirall, LLC | 837a7b23-ab14-4f23-873d-bdee95177691 | 2025-06-23 | Adverse reactions | CORDRAN FLURANDRENOLIDE |
| Flurandrenolide | FLURANDRENOLIDE | Bryant Ranch Prepack | 2718df54-7dc1-4ebc-8258-607bedcf5813 | 2023-08-17 | Adverse reactions | FLURANDRENOLIDE |
| Flurandrenolide | FLURANDRENOLIDE | Bryant Ranch Prepack | 3868377d-bee3-42f4-8c72-319e84e7d5bd | 2023-07-17 | Adverse reactions | FLURANDRENOLIDE |
| Flurandrenolide | FLURANDRENOLIDE | Padagis Israel Pharmaceuticals Ltd | 9c4f5aea-2e08-400c-88f6-d9e3013afda7 | 2022-10-11 | Adverse reactions | FLURANDRENOLIDE |
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 |
|---|---|---|---|---|---|
| 16110-052 | Cordran | flurandrenolide | Almirall, LLC | NDA | Current |
| 16110-052 | Cordran | flurandrenolide | Aqua Pharmaceuticals | NDA | Current |
| 16110-052 | Cordran | flurandrenolide | Almirall, LLC | NDA | Current |
| 51672-5298 | Flurandrenolide | Flurandrenolide | Taro Pharmaceuticals U.S.A., Inc. | NDA | Current |
| 51672-5298 | Flurandrenolide | Flurandrenolide | Taro Pharmaceuticals U.S.A., Inc. | NDA | Current |