Application 076898
- Type
- ANDA
- Sponsor
- TEVA
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 |
|---|---|---|---|---|---|---|---|
| A076898-001 | CELECOXIB | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2014-05-30 | |
| A076898-002 | CELECOXIB | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2014-05-30 | |
| A076898-003 | CELECOXIB | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2014-05-30 | |
| A076898-004 | CELECOXIB | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2014-05-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076898-001 | AB |
| A076898-002 | AB |
| A076898-003 | AB |
| A076898-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076898-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2014-05-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076898-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2014-05-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076898-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2014-05-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076898-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2014-05-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076898-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2014-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076898-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2014-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076898-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2014-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076898-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2014-05-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076898-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2014-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076898-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2014-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076898-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2014-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076898-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2014-05-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076898-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2014-05-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076898-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2014-05-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076898-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2014-05-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076898-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2014-05-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076898-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2014-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076898-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2014-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076898-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2014-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076898-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2014-05-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076898-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2014-05-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076898-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2014-05-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076898-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2014-05-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076898-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2014-05-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076898-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2014-05-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076898-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2014-05-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076898-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2014-05-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076898-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2014-05-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076898-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2014-05-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076898-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2014-05-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076898-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2014-05-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076898-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2014-05-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076898-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2014-05-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076898-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2014-05-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076898-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2014-05-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076898-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2014-05-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076898-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2014-05-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076898-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2014-05-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076898-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2014-05-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076898-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2014-05-30 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076898-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076898-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076898-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076898-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076898-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076898-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076898-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076898-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076898-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076898-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076898-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076898-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076898-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076898-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076898-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076898-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076898-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076898-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076898-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076898-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076898-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076898-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076898-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076898-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076898-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076898-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076898-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076898-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076898-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076898-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076898-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076898-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076898-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076898-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076898-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076898-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076898-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076898-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076898-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076898-004 | AB | 1 | 5bbf6a4d5a75… |
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 | Major Pharmaceuticals | 3a1eadd5-c0a7-473e-bde0-6b9450d11c95 | 2026-09-02 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | REMEDYREPACK INC. | c96509cc-47f4-44f8-9f7e-4e49cc3d5348 | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | DirectRx | e0f3aacf-df5d-dad7-e053-2995a90ac5eb | 2026-08-27 | Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | A-S Medication Solutions | e84d67c8-010d-495c-8691-ae16d0698f8d | 2026-08-25 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | St. Mary's Medical Park Pharmacy | 59f495e8-3cea-9d98-e063-6394a90a89d4 | 2026-08-25 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Mullan Pharmaceutical Inc. | 643e177f-216d-4dfa-824a-7516a488304e | 2026-08-19 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | REMEDYREPACK INC. | b3acbfd9-a1c2-4aa6-b5f0-013cfad6cca8 | 2026-08-17 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | REMEDYREPACK INC. | e18d2fa4-4982-4e2a-af55-4319d6416efb | 2026-08-14 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | A-S Medication Solutions | d799328f-9ea0-4b64-9667-8feaa97f150c | 2026-08-07 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | PD-Rx Pharmaceuticals, Inc. | b06ced10-81c6-4f48-a205-1e0db228cb8b | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Alembic Pharmaceuticals Inc. | 806e5f8a-f986-4f88-ba3e-8265f86afa48 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| CELECOXIB | CELECOXIB | REMEDYREPACK INC. | 27f17ae7-939b-402e-9498-3b6611104089 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | CELECOXIB CELECOXIB |
| Celecoxib | CELECOXIB | PD-Rx Pharmaceuticals, Inc. | 06076494-62ad-4f58-b8bb-7038fcfe3b12 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | St. Mary's Medical Park Pharmacy | 3bc74e76-0517-69c6-e063-6394a90abe75 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Cardinal Health 107, LLC | a9114d6a-13d7-443c-be44-7866b4a4cf96 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| celecoxib | CELECOXIB | HAWAII REPACK, INC. | 45816eae-ad83-4d2f-a035-c3f9f24708f9 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | HAWAII REPACK, INC. | 77f3b90b-a25d-4c47-975a-2a988d696a3f | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | St Mary's Medical Park Pharmacy | e1ab644d-b668-3cf3-e053-2995a90addb0 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Radha Pharmaceuticals, Inc. | 2c86ece8-1cf5-4688-91b1-8aef5d60b7e4 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Bryant Ranch Prepack | d94849a7-1831-4319-982c-c6b20dc42038 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
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 |
|---|---|---|---|---|---|
| 0093-7165 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7165 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7165 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7165 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7165 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7165 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7165 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7165 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7166 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7166 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7166 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7166 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7166 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7166 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7166 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7166 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7170 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7170 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7170 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7170 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7170 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7170 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7170 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7170 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7306 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7306 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7306 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7306 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7306 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7306 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7306 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7306 | Celecoxib | Celecoxib | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 42708-016 | Celecoxib | Celecoxib | QPharma Inc | ANDA | Current |
| 42708-016 | Celecoxib | Celecoxib | QPharma Inc | ANDA | Current |
| 42708-016 | Celecoxib | Celecoxib | QPharma Inc | ANDA | Current |
| 43063-660 | Celecoxib | Celecoxib | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50436-3982 | Celecoxib | Celecoxib | Unit Dose Services | ANDA | Current |
| 60760-208 | Celecoxib | Celecoxib | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 68084-969 | Celecoxib | Celecoxib | American Health Packaging | ANDA | Current |
| 68084-969 | Celecoxib | Celecoxib | American Health Packaging | ANDA | Current |
| 68084-976 | Celecoxib | Celecoxib | American Health Packaging | ANDA | Current |
| 68084-976 | Celecoxib | Celecoxib | American Health Packaging | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8977 | ORIG | 2014-06-02 |