Application 074846
- Type
- ANDA
- Sponsor
- INVATECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ETODOLAC | ETODOLAC | TABLET;ORAL | 400MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074846-001 | ETODOLAC | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 |
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 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A074846-001 | ETODOLAC | 400MG | TABLET / ORAL | 1997-02-28 | 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 |
|---|---|---|---|---|---|---|
| Etodolac | ETODOLAC | Aurobindo Pharma Limited | c74c3c56-a5ac-40b4-974b-c4f4b05c5df9 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | Sun Pharmaceutical Industries, Inc. | ec82b108-6a6f-4d1b-82cb-831d4ed36c80 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | TaSun Pharmaceutical Industries, Inc. | 2c5b44b4-78d5-43b2-827d-d2763b6672b3 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | St. Marys Medical Park Pharmacy | 60cb4de0-ed88-a46b-e053-2a91aa0a8b6d | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | REMEDYREPACK INC. | cad9b5ca-a9d4-41d4-aff2-67d0c458aad6 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | PD-Rx Pharmaceuticals, Inc. | 007c55fa-ef8b-4a8e-bfe5-e47c6e5da727 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | St. Mary's Medical Park Pharmacy | 6761e6b1-2399-4643-e053-2991aa0a6f17 | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | PD-Rx Pharmaceuticals, Inc. | 41bd86b9-2ef3-49a4-874e-fe8ac6891080 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | PD-Rx Pharmaceuticals, Inc. | 556eaa67-d30d-4095-a981-c65f98d3acdd | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | Preferred Pharmaceuticals Inc. | 117b3005-a8ec-4f76-824c-95ec42dc87a1 | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | Preferred Pharmaceuticals Inc. | 55ae2e78-d803-496b-b66d-af1140312785 | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | Bryant Ranch Prepack | ea12933b-2280-4a11-a0e3-554194c53c4d | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | Bryant Ranch Prepack | 301087e4-f05c-4fd3-8815-c86c6f12ff61 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | Bryant Ranch Prepack | a355160d-24c3-4a4d-99ea-84c80ce67f90 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | Bryant Ranch Prepack | e7a81661-28a2-40d7-8c90-786629c81e36 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | Bryant Ranch Prepack | 03458123-e27c-4447-9ef3-3bd32481cb97 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| etodolac | ETODOLAC | Ipca Laboratories Limited | f50a93ca-584a-4205-a79b-31bafdd309c2 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | etodolac ETODOLAC |
| etodolac | ETODOLAC | Ipca Laboratories Limited | d583988c-3e7e-4415-b2fd-34049791cd1c | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | etodolac ETODOLAC |
| Etodolac | ETODOLAC | A-S Medication Solutions | 336d5331-4d60-42e2-8cfc-aad57c01eda0 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |
| Etodolac | ETODOLAC | A-S Medication Solutions | 00125d63-d8d0-46c5-bdf1-80d2c85eda5a | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | Etodolac ETODOLAC |