Application 207095
- Type
- ANDA
- Sponsor
- SHANDONG XINHUA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 200MG | No | No |
| 002 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207095-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | ||
| A207095-002 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 |
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 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 87673890dc5c… |
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 |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | Shield Pharmaceuticals Corp | 1ca722bb-940e-4b3e-9561-d87e2feb1ff8 | 2026-07-24 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Shield Pharmaceuticals Corp | fc6c29b4-f1b3-4cfe-8c96-564d083be39c | 2026-07-24 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | PROSTAT FIRST AID | 3bca27b4-3df6-b7d1-e063-6394a90ac6af | 2025-08-07 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Trifecta Pharmaceuticals USA LLC | 37299475-e2f3-de26-e063-6394a90ad62d | 2025-06-09 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Allegiant Health | 2ea039d6-f522-4103-a1f9-5b80a3b12a27 | 2025-04-14 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Trifecta Pharmaceuticals USA LLC | 09972806-e064-238d-e063-6394a90a7434 | 2024-12-31 | Warnings | 207095 ANDA207095 |
| Ibuprofen 200mg | IBUPROFEN 200MG | Allegiant Health | 265e2b47-d14a-45a8-adc0-7214e2057103 | 2024-09-30 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Trifecta Pharmaceuticals USA LLC | 114b5e23-6cd7-41d8-e063-6294a90aa0f0 | 2024-06-12 | Warnings | 207095 ANDA207095 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 11788-003 | Ibuprofen | Ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-003 | Ibuprofen | Ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-005 | Ibuprofen | Ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-005 | Ibuprofen | Ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-007 | Ibuprofen | Ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-007 | Ibuprofen | Ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 58624-7007 | Ibuprofen | Ibuprofen | Shandong Xinhua Pharmaceutical Co., Ltd. | ANDA | Current |
| 58624-7008 | Ibuprofen | Ibuprofen | Shandong Xinhua Pharmaceutical Co., Ltd. | ANDA | Current |
| 58624-7009 | Ibuprofen | Ibuprofen | Shandong Xinhua Pharmaceutical Co., Ltd. | ANDA | Current |
| 58624-7010 | Ibuprofen | Ibuprofen | Shandong Xinhua Pharmaceutical Co., Ltd. | ANDA | Current |
| 58624-7011 | Ibuprofen | Ibuprofen | Shandong Xinhua Pharmaceutical Co., Ltd. | ANDA | Current |
| 58624-7012 | Ibuprofen | Ibuprofen | Shandong Xinhua Pharmaceutical Co., Ltd. | ANDA | Current |