Application 204519
- Type
- ANDA
- Sponsor
- ALEMBIC 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 |
|---|---|---|---|---|---|---|---|
| A204519-001 | CELECOXIB | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | |
| A204519-002 | CELECOXIB | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | |
| A204519-003 | CELECOXIB | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | |
| A204519-004 | CELECOXIB | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204519-001 | AB |
| A204519-002 | AB |
| A204519-003 | AB |
| A204519-004 | 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 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | 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 | A204519-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204519-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204519-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204519-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-004 | 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 | Alembic Pharmaceuticals Inc. | 806e5f8a-f986-4f88-ba3e-8265f86afa48 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 62332-140 62332-143 62332-142 62332-141 |
| Celecoxib | CELECOXIB | Cardinal Health 107, LLC | a9114d6a-13d7-443c-be44-7866b4a4cf96 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 |
| Celecoxib | CELECOXIB | AvPAK | 951df0f7-5fb7-40f5-e053-2995a90a1edd | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 50268-168 50268-169 |
| Celecoxib | CELECOXIB | Major Pharmaceuticals | 3a1eadd5-c0a7-473e-bde0-6b9450d11c95 | 2026-04-06 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 |
| Celecoxib | CELECOXIB | RedPharm Drug | 2fbaa580-f33a-417d-e063-6294a90ad7df | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 |
| Celecoxib | CELECOXIB | Alembic Pharmaceuticals Limited | 14e8d788-e44c-4a40-8678-25cf45fed477 | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 46708-270 46708-267 46708-269 46708-268 |
| Celecoxib 200 mg | CELECOXIB | Proficient Rx LP | feee6a01-63f9-42c3-8bd8-ca713a08b36d | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 63187-633 |
| Celecoxib | CELECOXIB | Proficient Rx LP | 7a234c0c-30a7-49f5-92a1-a1fc836ff9ae | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 71205-020 |
| Celecoxib | CELECOXIB | Proficient Rx LP | c787b0ab-77ab-4f7e-9fea-be2a0085020a | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 71205-055 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13811-658 | Celecoxib | Celecoxib | Trigen Laboratories, LLC | ANDA | Current |
| 13811-659 | Celecoxib | Celecoxib | Trigen Laboratories, LLC | ANDA | Current |
| 13811-660 | Celecoxib | Celecoxib | Trigen Laboratories, LLC | ANDA | Current |
| 13811-661 | Celecoxib | Celecoxib | Trigen Laboratories, LLC | ANDA | Current |
| 45865-943 | Celecoxib | Celecoxib | medsource pharmaceuticals | ANDA | Current |
| 46708-267 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-267 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-268 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-268 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-269 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-269 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-270 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-270 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 50268-168 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-168 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-168 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-168 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-169 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-169 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-169 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-169 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 53002-1338 | Celecoxib | Celecoxib | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1338 | Celecoxib | Celecoxib | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-206 | Celecoxib 200 mg | CELECOXIB | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 59088-723 | CeleXib 100-EZS | Celecoxib | PureTek Corporation | ANDA | Current |
| 62332-140 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-140 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-140 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-140 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-140 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-141 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-141 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-141 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-141 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-141 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-142 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-142 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-142 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-142 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-142 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-143 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-143 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-143 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-143 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-143 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 63187-633 | Celecoxib 200 mg | CELECOXIB | Proficient Rx LP | ANDA | Current |
| 63187-633 | Celecoxib 200 mg | CELECOXIB | Proficient Rx LP | ANDA | Current |
| 67296-1600 | Celecoxib | Celecoxib | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1600 | Celecoxib | Celecoxib | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1600 | Celecoxib | Celecoxib | RedPharm Drug, Inc. | ANDA | Current |
| 68071-4476 | Celecoxib | Celecoxib | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4476 | Celecoxib | Celecoxib | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-8969 | Celecoxib 200 mg | CELECOXIB | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69399-182 | Celecoxib 50 mg | CELECOXIB | SYDON LABS LLC | ANDA | Current |
| 69399-183 | Celecoxib 100 mg | CELECOXIB | SYDON LABS LLC | ANDA | Current |
| 69399-184 | Celecoxib 200 mg | CELECOXIB | SYDON LABS LLC | ANDA | Current |
| 69399-185 | Celecoxib 400 mg | CELECOXIB | SYDON LABS LLC | ANDA | Current |
| 69399-194 | Celecoxib 200 mg | CELECOXIB | SYDON LABS LLC | ANDA | Current |
| 71205-020 | Celecoxib | Celecoxib | Proficient Rx LP | ANDA | Current |
| 71205-020 | Celecoxib | Celecoxib | Proficient Rx LP | ANDA | Current |
| 71205-055 | Celecoxib | Celecoxib | Proficient Rx LP | ANDA | Current |
| 71205-055 | Celecoxib | Celecoxib | Proficient Rx LP | ANDA | Current |
| 80175-0142 | celecoxib | celecoxib | Central Packaging | ANDA | Current |
| 80175-0142 | celecoxib | celecoxib | Central Packaging | ANDA | Current |