Application 208501
- Type
- ANDA
- Sponsor
- PAR PHARM INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ETHACRYNIC ACID | ETHACRYNIC ACID | TABLET;ORAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208501-001 | ETHACRYNIC ACID | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | 2017-07-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208501-001 | ETHACRYNIC ACID | 25MG | TABLET / ORAL | AB | 2017-07-21 | cb3db0bc1861… |
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 | A208501-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A208501-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A208501-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A208501-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A208501-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A208501-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208501-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A208501-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A208501-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A208501-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A208501-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A208501-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A208501-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208501-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A208501-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A208501-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208501-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208501-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208501-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208501-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A208501-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A208501-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208501-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A208501-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A208501-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208501-001 | 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 |
|---|---|---|---|---|---|---|
| Ethacrynic Acid | ETHACRYNIC ACID | Upsher-Smith Laboratories, LLC | c0b17629-7e4a-4c9c-9577-4f7904564628 | 2026-07-06 | Warnings, Adverse reactions | Ethacrynic Acid ETHACRYNIC ACID |
| Ethacrynic Acid | ETHACRYNIC ACID | St. Mary's Medical Park Pharmacy | f4e95ca1-502b-5305-e053-2995a90a5dc7 | 2026-06-26 | Warnings, Adverse reactions | Ethacrynic Acid ETHACRYNIC ACID |
| Ethacrynic Acid | ETHACRYNIC ACID | Amneal Pharmaceuticals NY LLC | b9bc3907-bfa7-4d9f-90d9-c2097230f7e4 | 2026-04-14 | Warnings, Adverse reactions | Ethacrynic Acid ETHACRYNIC ACID |
| Ethacrynic acid | ETHACRYNIC ACID | TRUPHARMA LLC | 3b2b6ee1-1859-4b02-9ef2-5bbe6427f61a | 2025-12-01 | Warnings, Adverse reactions | Ethacrynic acid ETHACRYNIC ACID |
| Ethacrynic Acid | ETHACRYNIC ACID | Lupin Pharmaceuticals, Inc. | 358dd0c5-4d89-403e-9428-a785ec862869 | 2025-10-30 | Warnings, Adverse reactions | Ethacrynic Acid ETHACRYNIC ACID |
| Ethacrynic Acid | ETHACRYNIC ACID | Edenbridge Pharmaceuticals LLC. | de7c25a6-ed00-4ef3-883d-f8841f5dbd02 | 2025-08-11 | Warnings, Adverse reactions | Ethacrynic Acid ETHACRYNIC ACID |
| Ethacrynic Acid | ETHACRYNIC ACID | Bryant Ranch Prepack | fd1b7fb4-fe56-4f2d-860d-bbcea16adfea | 2025-02-04 | Warnings, Adverse reactions | Ethacrynic Acid ETHACRYNIC ACID |
| Ethacrynic Acid | ETHACRYNIC ACID | ScieGen Pharmaceuticals Inc | d400d264-c231-4bdf-8180-eb11ab4e9f29 | 2024-12-24 | Warnings, Adverse reactions | Ethacrynic Acid ETHACRYNIC ACID |
| ethacrynic acid | ETHACRYNIC ACID | Oceanside Pharmaceuticals | f127598f-e6b3-4c35-800f-76e4217595ae | 2023-08-31 | Warnings, Adverse reactions | ethacrynic acid ETHACRYNIC ACID |
| EDECRIN | ETHACRYNIC ACID | Bausch Health US, LLC | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 | 2020-08-31 | Warnings, Adverse reactions | ETHACRYNIC ACID |