Application 078857
- Type
- ANDA
- Sponsor
- MYLAN
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 |
|---|---|---|---|---|---|---|---|
| A078857-001 | CELECOXIB | CELECOXIB | 50MG | CAPSULE / ORAL | 2014-05-30 | ||
| A078857-002 | CELECOXIB | CELECOXIB | 100MG | CAPSULE / ORAL | 2015-02-11 | ||
| A078857-003 | CELECOXIB | CELECOXIB | 200MG | CAPSULE / ORAL | 2015-02-11 | ||
| A078857-004 | CELECOXIB | CELECOXIB | 400MG | CAPSULE / ORAL | 2015-02-11 |
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 | A078857-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2014-05-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078857-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2015-02-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078857-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2015-02-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078857-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2015-02-11 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078857-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2014-05-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078857-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2015-02-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078857-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2015-02-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078857-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2015-02-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078857-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2014-05-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078857-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2015-02-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078857-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2015-02-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078857-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2015-02-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078857-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2014-05-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078857-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2015-02-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078857-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2015-02-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078857-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2015-02-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078857-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2014-05-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078857-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2015-02-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078857-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2015-02-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078857-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2015-02-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078857-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2014-05-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078857-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2015-02-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078857-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2015-02-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078857-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2015-02-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078857-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2014-05-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078857-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2015-02-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078857-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2015-02-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078857-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2015-02-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078857-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2014-05-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078857-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2015-02-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078857-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2015-02-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078857-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2015-02-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078857-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2014-05-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078857-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2015-02-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078857-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2015-02-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078857-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2015-02-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078857-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2014-05-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078857-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2015-02-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078857-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2015-02-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078857-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2015-02-11 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078857-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078857-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078857-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078857-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078857-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078857-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078857-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078857-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078857-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078857-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078857-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078857-004 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078857-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078857-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078857-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078857-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078857-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078857-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078857-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078857-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078857-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078857-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078857-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078857-004 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078857-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078857-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078857-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078857-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A078857-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A078857-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A078857-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A078857-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A078857-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A078857-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A078857-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A078857-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A078857-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078857-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078857-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078857-004 | AB | 1 | c0c555d07b60… |
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. | e18d2fa4-4982-4e2a-af55-4319d6416efb | 2026-08-14 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| CELECOXIB | CELECOXIB | American Health Packaging | 4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc7 | 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 | St. Mary's Medical Park Pharmacy | 57b07096-6d7c-1653-e063-6294a90aa6e2 | 2026-07-24 | 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 |
| 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-7150 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7150 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7150 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7150 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7150 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7150 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7160 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7160 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7160 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7160 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7160 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7160 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7165 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7165 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7165 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7165 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7165 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7165 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7170 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7170 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7170 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7170 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7170 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7170 | Celecoxib | celecoxib | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 43353-257 | Celecoxib | celecoxib | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 51079-199 | Celecoxib | celecoxib | Mylan Institutional Inc. | ANDA | Current |
| 51079-199 | Celecoxib | celecoxib | Mylan Institutional Inc. | ANDA | Current |
| 51079-199 | Celecoxib | celecoxib | Mylan Institutional Inc. | ANDA | Current |
| 51079-215 | Celecoxib | celecoxib | Mylan Institutional Inc. | ANDA | Current |
| 51079-215 | Celecoxib | celecoxib | Mylan Institutional Inc. | ANDA | Current |
| 51079-215 | Celecoxib | celecoxib | Mylan Institutional Inc. | ANDA | Current |
| 60429-459 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-459 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-459 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-460 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-460 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-460 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-460 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-460 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-461 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-461 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-461 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-461 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-461 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-462 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-462 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-462 | Celecoxib | celecoxib | Golden State Medical Supply, Inc. | ANDA | Current |
| 71335-0437 | Celecoxib | celecoxib | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31392 | ORIG | 2014-06-02 |