Application 076004
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ETODOLAC | ETODOLAC | TABLET;ORAL | 400MG | No | No |
| 002 | ETODOLAC | ETODOLAC | TABLET;ORAL | 500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076004-001 | ETODOLAC | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | |
| A076004-002 | ETODOLAC | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076004-001 | AB |
| A076004-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076004-001 | ETODOLAC | 400MG | TABLET / ORAL | AB | 2002-12-03 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076004-002 | ETODOLAC | 500MG | TABLET / ORAL | AB | 2002-12-03 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A076004-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A076004-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076004-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A076004-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076004-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076004-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076004-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A076004-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076004-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A076004-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076004-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076004-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076004-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076004-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076004-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076004-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076004-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076004-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076004-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076004-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A076004-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A076004-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A076004-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A076004-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076004-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076004-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076004-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076004-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076004-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076004-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076004-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076004-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A076004-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A076004-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A076004-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A076004-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076004-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076004-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A076004-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A076004-002 | AB | 1 | f41ea6bd6efb… |
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 | St. Marys Medical Park Pharmacy | 60cb4de0-ed88-a46b-e053-2a91aa0a8b6d | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 60760-552 |
| Etodolac | ETODOLAC | REMEDYREPACK INC. | cad9b5ca-a9d4-41d4-aff2-67d0c458aad6 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 |
| Etodolac | ETODOLAC | PD-Rx Pharmaceuticals, Inc. | 007c55fa-ef8b-4a8e-bfe5-e47c6e5da727 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 43063-856 |
| Etodolac | ETODOLAC | PD-Rx Pharmaceuticals, Inc. | 41bd86b9-2ef3-49a4-874e-fe8ac6891080 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 43063-671 |
| Etodolac | ETODOLAC | PD-Rx Pharmaceuticals, Inc. | 556eaa67-d30d-4095-a981-c65f98d3acdd | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 43063-578 |
| Etodolac | ETODOLAC | PD-Rx Pharmaceuticals, Inc. | 80e9d756-9278-48bb-bfdd-7d070ae0f341 | 2025-12-16 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 |
| Etodolac | ETODOLAC | Bryant Ranch Prepack | 479bce92-2066-46ed-b4bb-8c7a59edfffd | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 63629-8805 |
| Etodolac | ETODOLAC | Apotex Corp. | 4d682f98-1e8a-4c2b-6df3-169d2ed10dc1 | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 60505-0041 60505-0102 |
| Etodolac | ETODOLAC | Preferred Pharmaceuticals Inc. | 556a7d5f-2c3c-4efb-ac0c-fca140791602 | 2025-03-24 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 |
| Etodolac | ETODOLAC | Advanced Rx Pharmacy of Tennessee, LLC | d83d9f30-c367-f8b3-e053-2a95a90a1f40 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 |
| Etodolac | ETODOLAC | Bryant Ranch Prepack | be53bc5c-4294-44a7-b28c-7db3f925396d | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 |
| Etodolac | ETODOLAC | Aphena Pharma Solutions - Tennessee, LLC | 141be3f6-198d-ce46-e063-6294a90a7993 | 2024-03-20 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 |
| Etodolac | ETODOLAC | Medsource Pharmaceuticals | 12f0685b-2127-d0d6-e063-6394a90a62d1 | 2024-03-05 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 |
| Etodolac | ETODOLAC | Proficient Rx LP | e2fef939-2f4a-46ae-8177-073f5e8f57f5 | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 63187-736 |
| Etodolac | ETODOLAC | A-S Medication Solutions | 74baa6ad-b517-48e2-8cef-d77f5755b279 | 2023-02-04 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 50090-1790 |
| Etodolac | ETODOLAC | Proficient Rx LP | 0c783997-6f2a-45ae-b899-c060c8be468a | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 076004 ANDA076004 |
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 |
|---|---|---|---|---|---|
| 43063-578 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-578 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-578 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-578 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-671 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-671 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-671 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-671 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-671 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-856 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-856 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-856 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-856 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-856 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-856 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-856 | Etodolac | Etodolac | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-1789 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-1789 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-1789 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-1789 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-1789 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-1789 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-1789 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-1790 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-1790 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-1790 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-1790 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-2133 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-2133 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-2133 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-2133 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-2133 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50090-2133 | Etodolac | Etodolac | A-S Medication Solutions | ANDA | Current |
| 50436-0041 | Etodolac | Etodolac | Unit Dose Services | ANDA | Current |
| 53217-362 | Etodolac | Etodolac | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53217-371 | Etodolac | Etodolac | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55700-592 | Etodolac | Etodolac | Quality Care Products LLC | ANDA | Current |
| 55700-592 | Etodolac | Etodolac | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-592 | Etodolac | Etodolac | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-592 | Etodolac | Etodolac | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-592 | Etodolac | Etodolac | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-592 | Etodolac | Etodolac | Quality Care Products LLC | ANDA | Current |
| 55700-592 | Etodolac | Etodolac | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-592 | Etodolac | Etodolac | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-757 | Etodolac | Etodolac | Quality Care Products, LLC | ANDA | Current |
| 55700-757 | Etodolac | Etodolac | Quality Care Products, LLC | ANDA | Current |
| 55700-757 | Etodolac | Etodolac | Quality Care Products, LLC | ANDA | Current |
| 60505-0041 | Etodolac | Etodolac | Apotex Corp. | ANDA | Current |
| 60505-0041 | Etodolac | Etodolac | Apotex Corp. | ANDA | Current |
| 60505-0041 | Etodolac | Etodolac | Apotex Corp. | ANDA | Current |
| 60505-0041 | Etodolac | Etodolac | Apotex Corp. | ANDA | Current |
| 60505-0041 | Etodolac | Etodolac | Apotex Corp. | ANDA | Current |
| 60505-0041 | Etodolac | Etodolac | Apotex Corp. | ANDA | Current |
| 60505-0102 | Etodolac | Etodolac | Apotex Corp. | ANDA | Current |
| 60505-0102 | Etodolac | Etodolac | Apotex Corp. | ANDA | Current |
| 60505-0102 | Etodolac | Etodolac | Apotex Corp. | ANDA | Current |
| 60505-0102 | Etodolac | Etodolac | Apotex Corp. | ANDA | Current |
| 60505-0102 | Etodolac | Etodolac | Apotex Corp. | ANDA | Current |
| 60505-0102 | Etodolac | Etodolac | Apotex Corp. | ANDA | Current |
| 60760-552 | Etodolac | Etodolac | St. Mary | ANDA | Current |
| 60760-552 | Etodolac | Etodolac | St. Mary | ANDA | Current |
| 60760-552 | Etodolac | Etodolac | St. Mary | ANDA | Current |
| 61919-251 | ETODOLAC | ETODOLAC | DIRECT RX | ANDA | Current |
| 61919-251 | ETODOLAC | ETODOLAC | DIRECT RX | ANDA | Current |
| 61919-251 | ETODOLAC | ETODOLAC | DIRECT RX | ANDA | Current |
| 61919-784 | ETODOLAC | ETODOLAC | DIRECT RX | ANDA | Current |
| 61919-784 | ETODOLAC | ETODOLAC | DIRECT RX | ANDA | Current |
| 61919-858 | ETODOLAC | ETODOLAC | DIRECT RX | ANDA | Current |
| 63187-736 | Etodolac | Etodolac | Proficient Rx LP | ANDA | Current |
| 63187-736 | Etodolac | Etodolac | Proficient Rx LP | ANDA | Current |
| 63187-736 | Etodolac | Etodolac | Proficient Rx LP | ANDA | Current |
| 63629-8805 | Etodolac | Etodolac | Bryant Ranch Prepack | ANDA | Current |
| 63629-8805 | Etodolac | Etodolac | Bryant Ranch Prepack | ANDA | Current |
| 66267-095 | Etodolac | Etodolac | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-095 | Etodolac | Etodolac | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6901 | Etodolac | Etodolac | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6901 | Etodolac | Etodolac | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9410 | Etodolac | Etodolac | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9410 | Etodolac | Etodolac | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9410 | Etodolac | Etodolac | Preferred Pharmaceuticals Inc. | ANDA | Current |