Application 207446
- Type
- ANDA
- Sponsor
- CIPLA
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 |
|---|---|---|---|---|---|---|---|
| A207446-001 | CELECOXIB | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-09-23 | |
| A207446-002 | CELECOXIB | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-09-23 | |
| A207446-003 | CELECOXIB | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-09-23 | |
| A207446-004 | CELECOXIB | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-09-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207446-001 | AB |
| A207446-002 | AB |
| A207446-003 | AB |
| A207446-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207446-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-09-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207446-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-09-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207446-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-09-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207446-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-09-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207446-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-09-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207446-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-09-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207446-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-09-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207446-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-09-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207446-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-09-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207446-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-09-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207446-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-09-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207446-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-09-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207446-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-09-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207446-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-09-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207446-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-09-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207446-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-09-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207446-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-09-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207446-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-09-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207446-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-09-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207446-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-09-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207446-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-09-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207446-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-09-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207446-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-09-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207446-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-09-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207446-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-09-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207446-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-09-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207446-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-09-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207446-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-09-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207446-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-09-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207446-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-09-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207446-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-09-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207446-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-09-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207446-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-09-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207446-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-09-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207446-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-09-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207446-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-09-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207446-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-09-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207446-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-09-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207446-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-09-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207446-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-09-23 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207446-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207446-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207446-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207446-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207446-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207446-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207446-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207446-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207446-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207446-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207446-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207446-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207446-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207446-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207446-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207446-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207446-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207446-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207446-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207446-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207446-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207446-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207446-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207446-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207446-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207446-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207446-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207446-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207446-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207446-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207446-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207446-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207446-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207446-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207446-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207446-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207446-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207446-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207446-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207446-004 | AB | 1 | d06236e962d9… |
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. | 27f17ae7-939b-402e-9498-3b6611104089 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 207446 ANDA207446 70518-2233 |
| CELECOXIB | CELECOXIB | Northwind Health Company, LLC | f874eddf-b2f3-6830-e053-6394a90ade7a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 207446 ANDA207446 |
| CELECOXIB | CELECOXIB | Northwind Health Company, LLC | f2a0db9f-174b-1603-e053-2995a90a79a3 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 207446 ANDA207446 |
| CELECOXIB | CELECOXIB | A-S Medication Solutions | 95b2ced1-eca2-4c25-aa10-c9fb86b353a3 | 2025-05-30 | Boxed warning, Warnings, Adverse reactions | 207446 ANDA207446 |
| CELECOXIB | CELECOXIB | A-S Medication Solutions | 7b8e923c-253f-461e-94d7-669e75dc73e9 | 2025-05-30 | Boxed warning, Warnings, Adverse reactions | 207446 ANDA207446 |
| CELECOXIB | CELECOXIB | PD-Rx Pharmaceuticals, Inc. | 3191c9dc-bfdf-0591-e054-00144ff8d46c | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | 207446 ANDA207446 43063-669 |
| CELECOXIB | CELECOXIB | Quallent Pharmaceuticals Health LLC | aaa3a4f5-b281-415f-a08c-e0cefdae2fb5 | 2025-03-12 | Boxed warning, Warnings, Adverse reactions | 207446 ANDA207446 |
| CELECOXIB | CELECOXIB | Cipla USA Inc. | d12625b1-2af9-4532-af91-d40b65eeffef | 2025-03-12 | Boxed warning, Warnings, Adverse reactions | 207446 ANDA207446 69097-422 69097-423 69097-421 69097-420 |
| CELECOXIB | CELECOXIB | NorthStar RxLLC | ce61a585-5ac0-4185-99eb-a9511cd25a98 | 2025-03-12 | Boxed warning, Warnings, Adverse reactions | 207446 ANDA207446 16714-732 16714-733 16714-734 16714-731 |
| Celecoxib | CELECOXIB | Advanced Rx of Tennessee, LLC | af9d962a-5469-2039-e053-2a95a90ad59f | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 207446 ANDA207446 80425-0039 |
| Celecoxib | CELECOXIB | Advanced Rx Pharmacy of Tennessee, LLC | c1abc73e-c6ab-a0a5-e053-2a95a90a0817 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 207446 ANDA207446 80425-0142 |
| CELECOXIB | CELECOXIB | Proficient Rx LP | c91e5933-1798-4096-9f08-fb1200e154e1 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 207446 ANDA207446 63187-301 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-731 | CELECOXIB | CELECOXIB | NorthStar RxLLC | ANDA | Current |
| 16714-731 | CELECOXIB | CELECOXIB | NorthStar RxLLC | ANDA | Current |
| 16714-731 | CELECOXIB | CELECOXIB | NorthStar RxLLC | ANDA | Current |
| 16714-732 | CELECOXIB | CELECOXIB | NorthStar RxLLC | ANDA | Current |
| 16714-732 | CELECOXIB | CELECOXIB | NorthStar RxLLC | ANDA | Current |
| 16714-732 | CELECOXIB | CELECOXIB | NorthStar RxLLC | ANDA | Current |
| 16714-733 | CELECOXIB | CELECOXIB | NorthStar RxLLC | ANDA | Current |
| 16714-733 | CELECOXIB | CELECOXIB | NorthStar RxLLC | ANDA | Current |
| 16714-733 | CELECOXIB | CELECOXIB | NorthStar RxLLC | ANDA | Current |
| 16714-734 | CELECOXIB | CELECOXIB | NorthStar RxLLC | ANDA | Current |
| 16714-734 | CELECOXIB | CELECOXIB | NorthStar RxLLC | ANDA | Current |
| 16714-734 | CELECOXIB | CELECOXIB | NorthStar RxLLC | ANDA | Current |
| 43063-669 | CELECOXIB | CELECOXIB | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-669 | CELECOXIB | CELECOXIB | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-669 | CELECOXIB | CELECOXIB | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-669 | CELECOXIB | CELECOXIB | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-669 | CELECOXIB | CELECOXIB | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-669 | CELECOXIB | CELECOXIB | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-2394 | CELECOXIB | CELECOXIB | A-S Medication Solutions | ANDA | Current |
| 55700-449 | CELECOXIB | CELECOXIB | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-450 | CELECOXIB | CELECOXIB | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 63187-301 | CELECOXIB | CELECOXIB | Proficient Rx LP | ANDA | Current |
| 63187-301 | CELECOXIB | CELECOXIB | Proficient Rx LP | ANDA | Current |
| 67296-1345 | CELECOXIB | CELECOXIB | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1345 | CELECOXIB | CELECOXIB | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1345 | CELECOXIB | CELECOXIB | RedPharm Drug, Inc. | ANDA | Current |
| 68788-6393 | CELECOXIB | CELECOXIB | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69097-420 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-420 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-420 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-420 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-420 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-420 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-421 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-421 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-421 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-421 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-421 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-421 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-422 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-422 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-422 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-422 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-422 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-422 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-423 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-423 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-423 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-423 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-423 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 69097-423 | CELECOXIB | CELECOXIB | Cipla USA Inc. | ANDA | Current |
| 70518-2233 | CELECOXIB | CELECOXIB | REMEDYREPACK INC. | ANDA | Current |
| 70934-978 | CELECOXIB | CELECOXIB | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-978 | CELECOXIB | CELECOXIB | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-0450 | CELECOXIB | CELECOXIB | Bryant Ranch Prepack | ANDA | Current |
| 76282-692 | CELECOXIB | CELECOXIB | Exelan Pharmaceuticals, Inc | ANDA | Current |
| 76282-693 | CELECOXIB | CELECOXIB | Exelan Pharmaceuticals, Inc | ANDA | Current |
| 76282-694 | CELECOXIB | CELECOXIB | Exelan Pharmaceuticals, Inc | ANDA | Current |
| 76282-695 | CELECOXIB | CELECOXIB | Exelan Pharmaceuticals, Inc | ANDA | Current |
| 80425-0039 | Celebrex | Celecoxib 200mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0039 | Celecoxib | Celecoxib | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0039 | Celecoxib | Celecoxib | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0142 | Celebrex | Celecoxib 100mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0142 | Celebrex | Celecoxib 100mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0142 | Celecoxib | Celecoxib | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0142 | Celecoxib | Celecoxib | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0142 | Celecoxib | Celecoxib | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |