Application 206568
- Type
- ANDA
- Sponsor
- HUMANWELL PURACAP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IBUPROFEN | IBUPROFEN | CAPSULE;ORAL | EQ 200MG FREE ACID AND POTASSIUM SALT | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206568-001 | IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 |
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 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A206568-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2016-06-21 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0363-0743 | Ibuprofen minis | Ibuprofen | Walgreens | ANDA | Current |
| 0363-0743 | Ibuprofen minis | Ibuprofen | Walgreens | ANDA | Current |
| 0363-0743 | Ibuprofen minis | Ibuprofen | Walgreens | ANDA | Current |
| 0363-0743 | Ibuprofen minis | Ibuprofen | Walgreens | ANDA | Current |
| 0363-0743 | Ibuprofen minis | Ibuprofen | Walgreens | ANDA | Current |
| 0363-0749 | Ibuprofen | Ibuprofen | Walgreens | ANDA | Current |
| 0363-0749 | Ibuprofen | Ibuprofen | Walgreens | ANDA | Current |
| 0363-0749 | Ibuprofen | Ibuprofen | Walgreens | ANDA | Current |
| 0363-0945 | Ibuprofen | Ibuprofen | Walgreens | ANDA | Current |
| 0363-0945 | Ibuprofen | Ibuprofen | Walgreens | ANDA | Current |
| 0363-0945 | Ibuprofen | Ibuprofen | Walgreens | ANDA | Current |
| 0536-1147 | Ibuprofen | Ibuprofen | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1147 | Ibuprofen | Ibuprofen | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1147 | Ibuprofen | Ibuprofen | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1147 | Ibuprofen | Ibuprofen | Rugby Laboratories, Inc. | ANDA | Current |
| 11673-745 | Ibuprofen | Ibuprofen | TARGET Corporation | ANDA | Current |
| 11673-745 | Ibuprofen | Ibuprofen | TARGET Corporation | ANDA | Current |
| 11673-745 | Ibuprofen | Ibuprofen | TARGET Corporation | ANDA | Current |
| 11673-745 | Ibuprofen | Ibuprofen | TARGET Corporation | ANDA | Current |
| 11673-745 | Ibuprofen | Ibuprofen | TARGET Corporation | ANDA | Current |
| 11673-745 | Ibuprofen | Ibuprofen | TARGET Corporation | ANDA | Current |
| 11673-745 | Ibuprofen | Ibuprofen | TARGET Corporation | ANDA | Current |
| 11673-749 | Ibuprofen | Ibuprofen | TARGET Corporation | ANDA | Current |
| 11673-749 | Ibuprofen | Ibuprofen | TARGET Corporation | ANDA | Current |
| 11673-749 | Ibuprofen | Ibuprofen | TARGET Corporation | ANDA | Current |
| 21130-745 | Ibuprofen | Ibuprofen | Safeway, Inc. | ANDA | Current |
| 21130-745 | Ibuprofen | Ibuprofen | Safeway, Inc. | ANDA | Current |
| 21130-745 | Ibuprofen | Ibuprofen | Safeway, Inc. | ANDA | Current |
| 21130-745 | Ibuprofen | Ibuprofen | Safeway, Inc. | ANDA | Current |
| 21130-745 | Ibuprofen | Ibuprofen | Safeway, Inc. | ANDA | Current |
| 21130-843 | Ibuprofen minis | Ibuprofen | Safeway, Inc. | ANDA | Current |
| 21130-843 | Ibuprofen minis | Ibuprofen | Safeway, Inc. | ANDA | Current |
| 21130-843 | Ibuprofen minis | Ibuprofen | Safeway, Inc. | ANDA | Current |
| 21130-843 | Ibuprofen minis | Ibuprofen | Safeway, Inc. | ANDA | Current |
| 21130-843 | Ibuprofen minis | Ibuprofen | Safeway, Inc. | ANDA | Current |
| 30142-743 | Ibuprofen minis | Ibuprofen | The Kroger Co. | ANDA | Current |
| 30142-743 | Ibuprofen minis | Ibuprofen | The Kroger Co. | ANDA | Current |
| 30142-743 | Ibuprofen minis | Ibuprofen | The Kroger Co. | ANDA | Current |
| 30142-745 | Ibuprofen | Ibuprofen | The Kroger Co. | ANDA | Current |
| 30142-745 | Ibuprofen | Ibuprofen | The Kroger Co. | ANDA | Current |
| 30142-745 | Ibuprofen | Ibuprofen | The Kroger Co. | ANDA | Current |
| 30142-745 | Ibuprofen | Ibuprofen | The Kroger Co. | ANDA | Current |
| 33992-0745 | Ibuprofen | Ibuprofen | ASSURED / DOLLAR TREE (Greenbrier International, Inc.) | ANDA | Current |
| 33992-0745 | Ibuprofen | Ibuprofen | ASSURED / DOLLAR TREE (Greenbrier International, Inc.) | ANDA | Current |
| 33992-0745 | Ibuprofen | Ibuprofen | ASSURED / DOLLAR TREE (Greenbrier International, Inc.) | ANDA | Current |
| 33992-0843 | Ibuprofen Minis | Ibuprofen | ASSURED / DOLLAR TREE (Greenbrier International, Inc.) | ANDA | Current |
| 33992-0843 | Ibuprofen Minis | Ibuprofen | ASSURED / DOLLAR TREE (Greenbrier International, Inc.) | ANDA | Current |
| 33992-0843 | Ibuprofen Minis | Ibuprofen | ASSURED / DOLLAR TREE (Greenbrier International, Inc.) | ANDA | Current |
| 36800-348 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-348 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-348 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-348 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-440 | Ibuprofen | Ibuprofen | Topco Associates LLC | ANDA | Current |
| 36800-745 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-745 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-745 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-745 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-745 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-745 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-749 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-749 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-749 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-749 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 37012-745 | Ibuprofen | Ibuprofen | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37012-745 | Ibuprofen | Ibuprofen | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37012-745 | Ibuprofen | Ibuprofen | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37012-745 | Ibuprofen | Ibuprofen | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 41520-745 | Ibuprofen | Ibuprofen | Care One (American Sales Company) | ANDA | Current |
| 41520-745 | Ibuprofen | Ibuprofen | Care One (American Sales Company) | ANDA | Current |
| 41520-745 | Ibuprofen | Ibuprofen | Care One (American Sales Company) | ANDA | Current |
| 41520-943 | Ibuprofen minis | Ibuprofen | Care One (American Sales Company) | ANDA | Current |
| 41520-943 | Ibuprofen minis | Ibuprofen | Care One (American Sales Company) | ANDA | Current |
| 41520-943 | Ibuprofen minis | Ibuprofen | Care One (American Sales Company) | ANDA | Current |
| 46122-530 | Ibuprofen | Ibuprofen | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | ANDA | Current |
| 46122-530 | Ibuprofen | Ibuprofen | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | ANDA | Current |
| 46122-530 | Ibuprofen | Ibuprofen | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | ANDA | Current |
| 49035-265 | Ibuprofen minis | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | ANDA | Current |
| 49035-265 | Ibuprofen minis | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-265 | Ibuprofen minis | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-265 | Ibuprofen minis | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |