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 | REMEDYREPACK INC. | f5d0e5b9-97d8-42a4-a0a0-c09dde7008e6 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| celecoxib | CELECOXIB | PD-Rx Pharmaceuticals, Inc. | 78d59905-4a78-4d9f-ac29-58790a5b3a92 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | celecoxib CELECOXIB |
| CELECOXIB | CELECOXIB | Bryant Ranch Prepack | fd569104-8243-48fa-8e93-5a08654ad6dd | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | CELECOXIB CELECOXIB |
| Celecoxib | CELECOXIB | Redpharm Drug | 5250529a-6a03-78a1-e063-6294a90a47f9 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | PD-Rx Pharmaceuticals, Inc. | 52572bfb-43f0-4b55-b1fd-231a05c8b83e | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | AvPAK | 951df0f7-5fb7-40f5-e053-2995a90a1edd | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| celecoxib | CELECOXIB | Macleods Pharmaceuticals Limited | d14aecf5-16e9-459a-bda4-4ca8f290796a | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | REMEDYREPACK INC. | 56d64558-1fad-420e-8fcd-7103cd073127 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | ST. MARY'S MEDICAL PARK PHARMACY | ed2093f6-1606-100a-e053-2995a90a5b95 | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | REMEDYREPACK INC. | 56127f57-7810-4f5d-a11d-e08fb2ed138b | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Apotex Corp. | a62612b3-9564-2b34-be59-6aa5ac53679c | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Direct_Rx | 4b2ffbdb-1847-d93b-e063-6394a90a06f5 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Northwind Health Company, LLC | 0de7a6f8-baba-1fd0-e063-6394a90ad434 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| CELECOXIB | CELECOXIB | REMEDYREPACK INC. | d0ca85fa-8b80-4a48-a1a4-a1c181821c39 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | CELECOXIB CELECOXIB |
| Celecoxib | CELECOXIB | ST. MARY'S MEDICAL PARK PHARMACY | 4e57bd99-5b7a-c2c7-e063-6294a90afb8c | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | AiPing Pharmaceutical, Inc. | 89db0dec-3800-4d89-a765-24838f4d0c30 | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Preferred Pharmaceuticals Inc. | b0839895-6a36-4e4f-9336-98632b60622a | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Preferred Pharmaceuticals, Inc. | f2a5ffbd-49c4-4a97-867b-2b14a3675020 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| celecoxib | CELECOXIB | Preferred Pharmaceuticals Inc. | a6000132-ac6c-4b61-a98a-8cc2dd84b3f0 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Preferred Pharmaceuticals, Inc. | d35d9494-4190-41a8-80d4-c9d877c432e9 | 2026-03-24 | 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 |