Application 211043
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZINC SULFATE | ZILEUTON | TABLET, EXTENDED RELEASE;ORAL | 600MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211043-001 | ZILEUTON | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 |
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 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-05-03 | 5c6f7cd8ea54… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-05-03 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-05-03 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-05-03 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211043-001 | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2022-05-03 | 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 | A211043-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-10-28 04:53 UTC | 2022-10 | A211043-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A211043-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211043-001 | 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 |
|---|---|---|---|---|---|---|
| ZINC SULFATE | ZINC SULFATE | Camber Pharmaceuticals, Inc. | 49698d00-f44b-4b1f-ae34-6b9067911757 | 2026-03-04 | Warnings, Adverse reactions | ZINC SULFATE |
| ZYFLO | ZILEUTON | Chiesi USA, Inc. | aee65202-fddb-497f-9f11-17cc727cb157 | 2025-11-30 | Warnings, Adverse reactions | ZILEUTON |
| Zinc Sulfate | ZINC SULFATE | Piramal Critical Care Inc. | dfa8a859-c285-17a3-e053-2a95a90a9343 | 2025-10-07 | Warnings, Adverse reactions | Zinc Sulfate |
| Zinc Sulfate | ZINC SULFATE INJECTION | Apotex Corp | b9cf2dab-6ec8-e099-464a-af46a3601971 | 2025-01-16 | Warnings, Adverse reactions | Zinc Sulfate |
| Zinc Sulfate | ZINC SULFATE | Piramal Critical Care Inc. | 0b6078d9-624c-e162-e063-6394a90a147d | 2024-12-17 | Warnings, Adverse reactions | Zinc Sulfate |
| zinc sulfate | ZINC SULFATE INJECTION, | Zydus Pharmaceuticals USA Inc. | 95aa8437-10bc-4205-939f-d21d8fa52a00 | 2024-12-06 | Warnings, Adverse reactions | zinc sulfate |
| Zinc sulfate | ZINC SULFATE | Somerset Therapeutics, LLC | c9d45d0e-a165-4112-81f9-c0e455572ecf | 2024-07-18 | Warnings, Adverse reactions | Zinc sulfate |
| 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 |
| Zinc Sulfate | ZINC SULFATE | Gland Pharma Limited | 8f354f0a-4e10-4e4e-b86c-49d97cbd631d | 2023-09-07 | Warnings, Adverse reactions | Zinc Sulfate |
| zinc sulfate | ZINC SULFATE | Zydus Lifesciences Limited | 74d8d07b-cfd9-4262-b689-fea12673bbd1 | 2023-08-31 | zinc sulfate | |
| Zileuton | ZILEUTON | Golden State Medical Supply, Inc. | f7573809-7741-04c9-e053-6294a90ab193 | 2023-03-20 | Warnings, Adverse reactions | ZILEUTON |
| Zinc Sulfate | ZINC SULFATE | Fresenius Kabi USA, LLC | 37d54dcd-b720-4168-bfb2-c8f381466aac | 2023-01-04 | Warnings, Adverse reactions | Zinc Sulfate |
| 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 |
| Zinc Sulfate | ZINC SULFATE | American Regent, Inc. | 4b528c88-07a0-4dce-84c6-ccd32555bbff | 2020-10-01 | Warnings, Adverse reactions | Zinc Sulfate |