Application 213301
- Type
- ANDA
- Sponsor
- UNICHEM
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 |
|---|---|---|---|---|---|---|---|
| A213301-001 | CELECOXIB | CELECOXIB | 50MG | CAPSULE / ORAL | 2021-01-12 | ||
| A213301-002 | CELECOXIB | CELECOXIB | 100MG | CAPSULE / ORAL | 2021-01-12 | ||
| A213301-003 | CELECOXIB | CELECOXIB | 200MG | CAPSULE / ORAL | 2021-01-12 | ||
| A213301-004 | CELECOXIB | CELECOXIB | 400MG | CAPSULE / ORAL | 2021-01-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2021-12-28 21:50 UTC | 2021-12 | A213301-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2021-01-12 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213301-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2021-01-12 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213301-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2021-01-12 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213301-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2021-01-12 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213301-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2021-01-12 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213301-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2021-01-12 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213301-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2021-01-12 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213301-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2021-01-12 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A213301-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2021-01-12 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A213301-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2021-01-12 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A213301-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2021-01-12 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A213301-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2021-01-12 | 5aa47cf7b7d7… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213301-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2021-01-12 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213301-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2021-01-12 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213301-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2021-01-12 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213301-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2021-01-12 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A213301-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2021-01-12 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A213301-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2021-01-12 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A213301-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2021-01-12 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A213301-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2021-01-12 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A213301-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2021-01-12 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A213301-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2021-01-12 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A213301-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2021-01-12 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A213301-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2021-01-12 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213301-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2021-01-12 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213301-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2021-01-12 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213301-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2021-01-12 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213301-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2021-01-12 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213301-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2021-01-12 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213301-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2021-01-12 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213301-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2021-01-12 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213301-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2021-01-12 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213301-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2021-01-12 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213301-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2021-01-12 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213301-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2021-01-12 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213301-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2021-01-12 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213301-001 | CELECOXIB | 50MG | CAPSULE / ORAL | 2021-01-12 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213301-002 | CELECOXIB | 100MG | CAPSULE / ORAL | 2021-01-12 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213301-003 | CELECOXIB | 200MG | CAPSULE / ORAL | 2021-01-12 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213301-004 | CELECOXIB | 400MG | CAPSULE / ORAL | 2021-01-12 | 3f0d92c62455… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A213301-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A213301-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A213301-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A213301-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A213301-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A213301-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A213301-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A213301-004 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213301-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213301-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213301-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213301-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A213301-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A213301-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A213301-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A213301-004 | AB | 1 | 5aa47cf7b7d7… |
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 | Unichem Pharmaceuticals (USA), Inc. | 0e8484a8-04a6-4be3-8c5c-1883b0490d53 | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | 213301 ANDA213301 29300-157 29300-158 29300-374 29300-373 |
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 |
|---|---|---|---|---|---|
| 29300-157 | Celecoxib | Celecoxib | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-157 | Celecoxib | Celecoxib | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-157 | Celecoxib | Celecoxib | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-158 | Celecoxib | Celecoxib | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-158 | Celecoxib | Celecoxib | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-158 | Celecoxib | Celecoxib | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-373 | Celecoxib | Celecoxib | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-373 | Celecoxib | Celecoxib | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-373 | Celecoxib | Celecoxib | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-374 | Celecoxib | Celecoxib | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-374 | Celecoxib | Celecoxib | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-374 | Celecoxib | Celecoxib | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |