Application 212564
- Type
- ANDA
- Sponsor
- YABAO PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 100MG | No | No |
| 002 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 200MG | No | No |
| 003 | 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 |
|---|---|---|---|---|---|---|---|
| A212564-001 | CELECOXIB | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | ||
| A212564-002 | CELECOXIB | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | ||
| A212564-003 | CELECOXIB | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 |
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 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A212564-002 | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A212564-003 | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212564-002 | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212564-003 | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212564-002 | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212564-003 | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212564-002 | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212564-003 | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212564-002 | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212564-003 | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212564-002 | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212564-003 | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212564-002 | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212564-003 | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212564-002 | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212564-003 | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212564-002 | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212564-003 | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212564-002 | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212564-003 | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212564-002 | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212564-003 | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212564-002 | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212564-003 | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212564-002 | CELECOXIB | 200MG | CAPSULE / ORAL | 2023-04-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212564-003 | CELECOXIB | 400MG | CAPSULE / ORAL | 2023-04-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212564-001 | CELECOXIB | 100MG | CAPSULE / ORAL | 2023-04-10 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A212564-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A212564-002 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A212564-003 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A212564-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A212564-002 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A212564-003 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A212564-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A212564-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A212564-003 | AB | 1 | 053a50430f4f… |
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 | Bryant Ranch Prepack | 550c828b-8c88-4c47-a7b8-a436aed46dc7 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | CELECOXIB CELECOXIB |
| CELECOXIB | CELECOXIB | Bryant Ranch Prepack | deeecba5-7a76-444b-a891-b00b1fb16d51 | 2025-01-29 | Boxed warning, Warnings, Adverse reactions | CELECOXIB CELECOXIB |
| Celecoxib | CELECOXIB | EPIC PHARMA, LLC | ac670924-0a3f-4f94-ac01-9e3c3071c990 | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Cranbury Pharmaceuticals, LLC | 933532fa-044a-48b1-bbe4-28062564f98a | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Advanced Rx of Tennessee, LLC | af73fea0-5cd1-0fa2-e053-2a95a90af8fc | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Advanced Rx of Tennessee, LLC | af9d962a-5469-2039-e053-2a95a90ad59f | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Advanced Rx of Tennessee, LLC | af9da1f2-717b-32b6-e053-2995a90ae585 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Advanced Rx of Tennessee, LLC | b3545cfb-97c3-b896-e053-2a95a90a15a0 | 2024-12-31 | Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Advanced Rx Pharmacy of Tennessee, LLC | c8ade384-2072-2cc2-e053-2a95a90ae791 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Advanced Rx Pharmacy of Tennessee, LLC | c1abc73e-c6ab-a0a5-e053-2a95a90a0817 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Advanced Rx Pharmacy of Tennessee, LLC | f60394f5-fd69-929b-e053-2995a90a5793 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Advanced Rx Pharmacy of Tennessee, LLC | f8fdcc56-7a53-9a42-e053-6394a90a48d5 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Advanced Rx Pharmacy of Tennessee, LLC | f8fdd580-09da-9c1c-e053-6394a90a4706 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Modavar Pharmaceuticals LLC | b0f73074-f3d8-4812-8e64-f88a02869ed3 | 2024-12-27 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| celecoxib | CELECOXIB | Torrent Pharmaceuticals Limited | 862698b6-2cc9-4374-992d-024beae6eba3 | 2024-12-23 | Boxed warning, Warnings, Adverse reactions | celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Quality Care Products, LLC | fcf49d7f-8319-4051-b7ac-fe063268b39b | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Unichem Pharmaceuticals (USA), Inc. | 0e8484a8-04a6-4be3-8c5c-1883b0490d53 | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| celecoxib | CELECOXIB | Quality Care Products LLC | f0df546e-17c9-4e85-839d-336612d7b9e5 | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Bryant Ranch Prepack | 0d89c39e-4858-4255-9127-1366e005203c | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
| Celecoxib | CELECOXIB | Bryant Ranch Prepack | 0dc9020d-28f5-4c69-896c-87b38e3ddb88 | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | Celecoxib CELECOXIB |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.