Application 204590
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 50MG | No | No |
| 002 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 100MG | No | No |
| 003 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 200MG | No | No |
| 004 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 400MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204590-001 | CELECOXIB | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2016-03-16 | |
| A204590-002 | CELECOXIB | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2016-03-16 | |
| A204590-003 | CELECOXIB | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2016-03-16 | |
| A204590-004 | CELECOXIB | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2016-03-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204590-001 | AB |
| A204590-002 | AB |
| A204590-003 | AB |
| A204590-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A204590-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2016-03-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204590-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2016-03-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204590-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2016-03-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204590-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2016-03-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204590-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2016-03-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204590-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2016-03-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204590-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2016-03-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204590-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2016-03-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204590-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2016-03-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204590-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2016-03-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204590-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2016-03-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204590-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2016-03-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204590-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2016-03-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204590-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2016-03-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204590-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2016-03-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204590-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2016-03-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204590-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2016-03-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204590-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2016-03-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204590-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2016-03-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204590-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2016-03-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204590-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2016-03-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204590-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2016-03-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204590-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2016-03-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204590-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2016-03-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204590-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2016-03-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204590-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2016-03-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204590-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2016-03-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204590-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2016-03-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204590-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2016-03-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204590-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2016-03-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204590-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2016-03-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204590-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2016-03-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204590-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2016-03-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204590-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2016-03-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204590-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2016-03-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204590-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2016-03-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204590-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2016-03-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204590-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2016-03-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204590-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2016-03-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204590-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2016-03-16 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A204590-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204590-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204590-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204590-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204590-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204590-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204590-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204590-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204590-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204590-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204590-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204590-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204590-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204590-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204590-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204590-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204590-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204590-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204590-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204590-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204590-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204590-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204590-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204590-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204590-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204590-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204590-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204590-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204590-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204590-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204590-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204590-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204590-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204590-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204590-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204590-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204590-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204590-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204590-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204590-004 | AB | 1 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| celecoxib | CELECOXIB | HAWAII REPACK, INC. | 45816eae-ad83-4d2f-a035-c3f9f24708f9 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 |
| celecoxib | CELECOXIB | PD-Rx Pharmaceuticals, Inc. | 78d59905-4a78-4d9f-ac29-58790a5b3a92 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 43063-967 |
| celecoxib | CELECOXIB | Macleods Pharmaceuticals Limited | d14aecf5-16e9-459a-bda4-4ca8f290796a | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 33342-157 33342-156 33342-155 33342-158 |
| celecoxib | CELECOXIB | Preferred Pharmaceuticals Inc. | a6000132-ac6c-4b61-a98a-8cc2dd84b3f0 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 68788-7264 |
| celecoxib | CELECOXIB | Preferred Pharmaceuticals, Inc. | 2fc74af6-4573-411d-9082-f3edd44a52a4 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 68788-7286 |
| CELECOXIB | CELECOXIB | Direct Rx | ac87b4f9-3f66-8cf7-e053-2995a90ade0f | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 72189-123 |
| celecoxib | CELECOXIB | Sportpharm LLC | 1ae11faa-5bbe-49b7-a4dd-b573c304cf66 | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 |
| celecoxib | CELECOXIB | Northwind Health Company, LLC | c213e224-c2fb-726e-e053-2a95a90a21c5 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 51655-253 |
| celecoxib | CELECOXIB | Bryant Ranch Prepack | 351f5f07-bdd4-9893-e063-6394a90a7281 | 2025-05-14 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 |
| celecoxib | CELECOXIB | RedPharm Drug, Inc. | 50c29846-3426-0310-e054-00144ff8d46c | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 67296-1399 |
| celecoxib | CELECOXIB | Asclemed USA, Inc. | f6291230-7598-407a-aef0-ec1f09277d2a | 2025-03-27 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 |
| celecoxib | CELECOXIB | Bryant Ranch Prepack | ac5c0d72-1bb3-4065-b2f4-5516b0869775 | 2025-02-20 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 71335-0936 71335-0868 |
| Celecoxib | CELECOXIB | Advanced Rx of Tennessee, LLC | af73fea0-5cd1-0fa2-e053-2a95a90af8fc | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 |
| Celecoxib | CELECOXIB | Advanced Rx of Tennessee, LLC | b3545cfb-97c3-b896-e053-2a95a90a15a0 | 2024-12-31 | Warnings, Adverse reactions | 204590 ANDA204590 |
| Celecoxib | CELECOXIB | Advanced Rx Pharmacy of Tennessee, LLC | c8ade384-2072-2cc2-e053-2a95a90ae791 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 |
| Celecoxib | CELECOXIB | Advanced Rx Pharmacy of Tennessee, LLC | f8fdd580-09da-9c1c-e053-6394a90a4706 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 |
| celecoxib | CELECOXIB | Quality Care Products LLC | f0df546e-17c9-4e85-839d-336612d7b9e5 | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 55700-613 |
| celecoxib | CELECOXIB | NuCare Pharmaceuticals,Inc. | 69aebbab-9906-be86-e053-2991aa0aa8a5 | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 68071-4392 |
| celecoxib | CELECOXIB | Asclemed USA, Inc. | 2a926010-08e1-44dd-bc6d-ed15374bd0d3 | 2023-09-02 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 76420-009 |
| celecoxib | CELECOXIB | Proficient Rx LP | 0ad14a4e-2f05-4ce7-93d1-1cb7e4d8f7d0 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | 204590 ANDA204590 71205-439 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 33342-155 | celecoxib | celecoxib | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-155 | celecoxib | celecoxib | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-156 | celecoxib | celecoxib | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-156 | celecoxib | celecoxib | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-157 | celecoxib | celecoxib | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-157 | celecoxib | celecoxib | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-158 | celecoxib | celecoxib | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-158 | celecoxib | celecoxib | Macleods Pharmaceuticals Limited | ANDA | Current |
| 43063-967 | celecoxib | celecoxib | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-967 | celecoxib | celecoxib | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-967 | celecoxib | celecoxib | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-967 | celecoxib | celecoxib | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-967 | celecoxib | celecoxib | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-967 | celecoxib | celecoxib | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-967 | celecoxib | celecoxib | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-967 | celecoxib | celecoxib | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 51655-253 | celecoxib | celecoxib | Northwind Pharmaceuticals | ANDA | Current |
| 55700-607 | celecoxib | celecoxib | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-607 | celecoxib | celecoxib | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-607 | celecoxib | celecoxib | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-607 | celecoxib | celecoxib | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-613 | celecoxib | celecoxib | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-613 | celecoxib | celecoxib | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-613 | celecoxib | celecoxib | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-613 | celecoxib | celecoxib | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60760-823 | celecoxib | celecoxib | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-823 | celecoxib | celecoxib | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-824 | celecoxib | celecoxib | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-682 | CELECOXIB | CELECOXIB | DIRECT RX | ANDA | Current |
| 61919-682 | CELECOXIB | CELECOXIB | Direct_Rx | ANDA | Current |
| 61919-682 | CELECOXIB | CELECOXIB | Direct_Rx | ANDA | Current |
| 61919-682 | CELECOXIB | CELECOXIB | Direct_Rx | ANDA | Current |
| 61919-837 | CELECOXIB | CELECOXIB | DIRECT RX | ANDA | Current |
| 61919-837 | Celecoxib | Celecoxib | Direct_Rx | ANDA | Current |
| 61919-837 | Celecoxib | Celecoxib | Direct_Rx | ANDA | Current |
| 61919-837 | Celecoxib | Celecoxib | Direct_Rx | ANDA | Current |
| 61919-837 | Celecoxib | Celecoxib | Direct_Rx | ANDA | Current |
| 61919-837 | Celecoxib | Celecoxib | Direct_Rx | ANDA | Current |
| 67296-1399 | celecoxib | celecoxib | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1399 | celecoxib | celecoxib | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1399 | celecoxib | celecoxib | RedPharm Drug, Inc. | ANDA | Current |
| 68071-4392 | celecoxib | celecoxib | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4392 | celecoxib | celecoxib | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7264 | celecoxib | celecoxib | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7264 | celecoxib | celecoxib | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7264 | celecoxib | celecoxib | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7286 | celecoxib | celecoxib | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7286 | celecoxib | celecoxib | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7286 | celecoxib | celecoxib | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7286 | celecoxib | celecoxib | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1346 | celecoxib | celecoxib | REMEDYREPACK INC. | ANDA | Current |
| 70518-1346 | celecoxib | celecoxib | REMEDYREPACK INC. | ANDA | Current |
| 70518-1346 | celecoxib | celecoxib | REMEDYREPACK INC. | ANDA | Current |
| 70518-1346 | celecoxib | celecoxib | REMEDYREPACK INC. | ANDA | Current |
| 70518-1346 | celecoxib | celecoxib | REMEDYREPACK INC. | ANDA | Current |
| 70518-1346 | celecoxib | celecoxib | REMEDYREPACK INC. | ANDA | Current |
| 70518-1346 | celecoxib | celecoxib | REMEDYREPACK INC. | ANDA | Current |
| 70518-1346 | celecoxib | celecoxib | REMEDYREPACK INC. | ANDA | Current |
| 70518-1650 | celecoxib | celecoxib | REMEDYREPACK INC. | ANDA | Current |
| 70518-1650 | celecoxib | celecoxib | REMEDYREPACK INC. | ANDA | Current |
| 70518-2922 | celecoxib | celecoxib | REMEDYREPACK INC. | ANDA | Current |
| 70518-2922 | celecoxib | celecoxib | REMEDYREPACK INC. | ANDA | Current |
| 70934-220 | celecoxib | celecoxib | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-220 | celecoxib | celecoxib | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-027 | celecoxib | celecoxib | Proficient Rx LP | ANDA | Current |
| 71205-027 | celecoxib | celecoxib | Proficient Rx LP | ANDA | Current |
| 71205-027 | celecoxib | celecoxib | Proficient Rx LP | ANDA | Current |
| 71205-027 | celecoxib | celecoxib | Proficient Rx LP | ANDA | Current |
| 71205-027 | celecoxib | celecoxib | Proficient Rx LP | ANDA | Current |
| 71205-027 | celecoxib | celecoxib | Proficient Rx LP | ANDA | Current |
| 71205-439 | celecoxib | celecoxib | Proficient Rx LP | ANDA | Current |
| 71205-439 | celecoxib | celecoxib | Proficient Rx LP | ANDA | Current |
| 71335-0868 | celecoxib | celecoxib | Bryant Ranch Prepack | ANDA | Current |
| 71335-0868 | celecoxib | celecoxib | Bryant Ranch Prepack | ANDA | Current |
| 71335-0936 | celecoxib | celecoxib | Bryant Ranch Prepack | ANDA | Current |
| 71335-0936 | celecoxib | celecoxib | Bryant Ranch Prepack | ANDA | Current |
| 72189-123 | CELECOXIB | CELECOXIB | Direct Rx | ANDA | Current |
| 72189-123 | CELECOXIB | CELECOXIB | Direct Rx | ANDA | Current |
| 72189-123 | CELECOXIB | CELECOXIB | Direct Rx | ANDA | Current |
| 76420-009 | celecoxib | celecoxib | Asclemed USA, Inc. | ANDA | Current |