Application 022052
- Type
- NDA
- Sponsor
- CHIESI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZYFLO CR | ZILEUTON | TABLET, EXTENDED RELEASE;ORAL | 600MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022052-001 | ZYFLO CR | ZILEUTON | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 |
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| 2026-07 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N022052-001 | ZYFLO CR | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2007-05-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022052-001 | ZYFLO CR | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-05-30 | 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 | N022052-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022052-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022052-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022052-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022052-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022052-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022052-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022052-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022052-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022052-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022052-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022052-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022052-001 | AB | 1 | ea99ee380514… |
| 2023-01-26 05:58 UTC | 2023-01 | N022052-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022052-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022052-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022052-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022052-001 | 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 |
|---|---|---|---|---|---|---|
| ZYFLO | ZILEUTON | Chiesi USA, Inc. | aee65202-fddb-497f-9f11-17cc727cb157 | 2025-11-30 | Warnings, Adverse reactions | ZILEUTON |
| Zileuton | ZILEUTON | Rising Pharma Holdings, Inc. | fd382540-b390-4e86-a94a-988ea89c93a8 | 2024-05-15 | Warnings, Adverse reactions | ZILEUTON |
| Zileuton | ZILEUTON | NorthStar RxLLC | bc29c998-1324-46aa-8386-e5b2fc9e0b16 | 2024-05-02 | Warnings, Adverse reactions | ZILEUTON |
| Zileuton | ZILEUTON | Golden State Medical Supply, Inc. | f7573809-7741-04c9-e053-6294a90ab193 | 2023-03-20 | Warnings, Adverse reactions | ZILEUTON |
| Zileuton | ZILEUTON | Camber Pharmaceuticals, Inc. | 94313e24-9534-4b6c-b374-c436c4916303 | 2022-10-14 | Warnings, Adverse reactions | ZILEUTON |
| Zileuton | ZILEUTON | Strides Pharma Science Limited | a826d16f-df07-447b-b050-b9a02ea1f89e | 2022-07-29 | Warnings, Adverse reactions | ZILEUTON |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10122-902 | ZYFLO CR | zileuton | Chiesi USA, Inc. | NDA | Current |
| 10122-902 | ZYFLO CR | zileuton | Chiesi USA, Inc. | NDA | Current |
| 10122-902 | ZYFLO CR | zileuton | Chiesi USA, Inc. | NDA | Current |
| 66993-485 | Zileuton | Zileuton | Prasco, LLC | NDA AUTHORIZED | Current |
| 66993-485 | Zileuton | Zileuton | Prasco, LLC | NDA AUTHORIZED GENERIC | Current |
| 66993-485 | Zileuton | Zileuton | Prasco, LLC | NDA AUTHORIZED GENERIC | Current |
| 66993-485 | Zileuton | Zileuton | Prasco, LLC | NDA AUTHORIZED GENERIC | Current |
| 66993-485 | Zileuton | Zileuton | Prasco, LLC | NDA AUTHORIZED GENERIC | Current |