Application 214475
- Type
- ANDA
- Sponsor
- RISING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | CAPSULE;ORAL | EQ 400MG BASE | No | No |
| 002 | FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | CAPSULE;ORAL | EQ 200MG BASE | No | No |
| 003 | FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | CAPSULE;ORAL | EQ 300MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214475-001 | FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | RS | 2022-07-18 | |
| A214475-002 | FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE / ORAL | 2024-07-26 | ||
| A214475-003 | FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 300MG BASE | CAPSULE / ORAL | 2024-07-26 |
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 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | RS | 2022-07-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214475-002 | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE / ORAL | 2024-07-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214475-003 | FENOPROFEN CALCIUM | EQ 300MG BASE | CAPSULE / ORAL | 2024-07-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | RS | 2022-07-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214475-002 | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE / ORAL | 2024-07-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214475-003 | FENOPROFEN CALCIUM | EQ 300MG BASE | CAPSULE / ORAL | 2024-07-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | RS | 2022-07-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214475-002 | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE / ORAL | 2024-07-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214475-003 | FENOPROFEN CALCIUM | EQ 300MG BASE | CAPSULE / ORAL | 2024-07-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | RS | 2022-07-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214475-002 | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE / ORAL | 2024-07-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214475-003 | FENOPROFEN CALCIUM | EQ 300MG BASE | CAPSULE / ORAL | 2024-07-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | RS | 2022-07-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214475-002 | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE / ORAL | 2024-07-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214475-003 | FENOPROFEN CALCIUM | EQ 300MG BASE | CAPSULE / ORAL | 2024-07-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | RS | 2022-07-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214475-002 | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE / ORAL | 2024-07-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214475-003 | FENOPROFEN CALCIUM | EQ 300MG BASE | CAPSULE / ORAL | 2024-07-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | RS | 2022-07-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214475-002 | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE / ORAL | 2024-07-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214475-003 | FENOPROFEN CALCIUM | EQ 300MG BASE | CAPSULE / ORAL | 2024-07-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | RS | 2022-07-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | RS | 2022-07-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214475-002 | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE / ORAL | 2024-07-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214475-003 | FENOPROFEN CALCIUM | EQ 300MG BASE | CAPSULE / ORAL | 2024-07-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | RS | 2022-07-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214475-002 | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE / ORAL | 2024-07-26 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A214475-003 | FENOPROFEN CALCIUM | EQ 300MG BASE | CAPSULE / ORAL | 2024-07-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | AB | RS | 2022-07-18 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | AB | RS | 2022-07-18 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | AB | RS | 2022-07-18 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | AB | 2022-07-18 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | AB | 2022-07-18 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | AB | 2022-07-18 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | AB | 2022-07-18 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | AB | 2022-07-18 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | AB | 2022-07-18 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | AB | 2022-07-18 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | AB | 2022-07-18 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A214475-001 | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE / ORAL | AB | 2022-07-18 | 053a50430f4f… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214475-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214475-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214475-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A214475-001 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214475-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A214475-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A214475-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214475-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214475-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214475-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214475-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A214475-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A214475-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214475-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A214475-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A214475-001 | AB | 1 | e64feba35796… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-12-20 04:57 UTC | 2023-12 | A214475-001 | CGT | 2023-02-11 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214475-001 | CGT | 2023-02-11 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214475-001 | CGT | 2023-02-11 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214475-001 | CGT | 2023-02-11 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214475-001 | CGT | 2023-02-11 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A214475-001 | CGT | 2023-02-11 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A214475-001 | CGT | 2023-02-11 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214475-001 | CGT | 2023-02-11 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A214475-001 | CGT | 2023-02-11 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A214475-001 | CGT | 2023-02-11 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Fenoprofen calcium | FENOPROFEN CALCIUM | Atland Pharmaceuticals, LLC | b26c8351-a955-4685-adad-a7233db39d92 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 214475 ANDA214475 |
| FENOPRON TM | FENOPROFEN CALCIUM | Galt Pharmaceuticals, LLC | 2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0 | 2026-02-16 | Boxed warning, Warnings, Adverse reactions | 214475 ANDA214475 |
| FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | Rising Pharma Holdings, Inc. | 4aa38cca-9f8f-4ab6-8103-4f1f48801a43 | 2025-12-08 | Boxed warning, Warnings, Adverse reactions | 214475 ANDA214475 16571-688 |
| FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | Atland Pharmaceuticals, LLC | 3daa336f-2acf-4109-a360-b1d30b192d41 | 2024-03-27 | Boxed warning, Warnings, Adverse reactions | 214475 ANDA214475 |
| FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | Proficient Rx LP | 1d438989-6431-4c62-8f24-444475d423a3 | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | 214475 ANDA214475 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16571-688 | FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | Rising Pharma Holdings, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71960 | ORIG | 2022-08-30 |