Application 072326
- Type
- ANDA
- Sponsor
- DAVA PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | TABLET;ORAL | EQ 600MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A072326-001 | FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 |
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 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A072326-001 | FENOPROFEN CALCIUM | EQ 600MG BASE | TABLET / ORAL | 1988-08-17 | cb3db0bc1861… |
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 | Fenoprofen calcium FENOPROFEN CALCIUM |
| Fenoprofen Calcium | FENOPROFEN CALCIUM | Misemer Pharmaceuticals, Inc. | d33ad329-1ca6-ac2e-e053-2995a90a15c5 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | Fenoprofen Calcium FENOPROFEN CALCIUM |
| FENOPRON TM | FENOPROFEN CALCIUM | Galt Pharmaceuticals, LLC | 2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0 | 2026-02-16 | Boxed warning, Warnings, Adverse reactions | FENOPROFEN CALCIUM |
| FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | Rising Pharma Holdings, Inc. | 4aa38cca-9f8f-4ab6-8103-4f1f48801a43 | 2025-12-08 | Boxed warning, Warnings, Adverse reactions | FENOPROFEN CALCIUM FENOPROFEN CALCIUM |
| FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | Atland Pharmaceuticals, LLC | 3daa336f-2acf-4109-a360-b1d30b192d41 | 2024-03-27 | Boxed warning, Warnings, Adverse reactions | FENOPROFEN CALCIUM FENOPROFEN CALCIUM |
| FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | Proficient Rx LP | 1d438989-6431-4c62-8f24-444475d423a3 | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | FENOPROFEN CALCIUM FENOPROFEN CALCIUM |