Application 078682
- Type
- ANDA
- Sponsor
- BIONPHARMA INC
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 |
|---|---|---|---|---|---|---|---|
| A078682-001 | IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 |
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 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 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 |
|---|---|---|---|---|---|
| 0363-0103 | Dye-Free Ibuprofen 200 | Ibuprofen | WALGREEN COMPANY | ANDA | Current |
| 0363-0103 | Dye-Free Ibuprofen 200 | Ibuprofen | WALGREEN COMPANY | ANDA | Current |
| 0363-0103 | Dye-Free Ibuprofen 200 | Ibuprofen | WALGREEN COMPANY | ANDA | Current |
| 0363-0197 | Ibuprofen | Ibuprofen | Walgreens | ANDA | Current |
| 0363-0197 | Ibuprofen | Ibuprofen | Walgreens | ANDA | Current |
| 0363-0221 | Ibuprofen | Ibuprofen | WALGREEN COMPANY | ANDA | Current |
| 0363-0221 | Ibuprofen | Ibuprofen | WALGREEN COMPANY | ANDA | Current |
| 0363-0221 | Ibuprofen | Ibuprofen | WALGREEN COMPANY | ANDA | Current |
| 0363-0222 | Ibuprofen 200 | Ibuprofen | WALGREEN COMPANY | ANDA | Current |
| 0363-0225 | Dye-Free Ibuprofen 200 | Ibuprofen | WALGREEN COMPANY | ANDA | Current |
| 0363-0225 | Dye-Free Ibuprofen 200 | Ibuprofen | WALGREEN COMPANY | ANDA | Current |
| 0363-0225 | Dye-Free Ibuprofen 200 | Ibuprofen | WALGREEN COMPANY | ANDA | Current |
| 0363-0240 | Migraine Relief | Ibuprofen | WALGREENS | ANDA | Current |
| 0363-0240 | Migraine Relief | Ibuprofen | WALGREENS | ANDA | Current |
| 0363-0240 | Migraine Relief | Ibuprofen | WALGREENS | ANDA | Current |
| 0363-0408 | Ibuprofen | Ibuprofen | Walgreens | ANDA | Current |
| 0536-3603 | Ibuprofen | IBUPROFEN | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-3603 | Ibuprofen | IBUPROFEN | Rugby Laboratories, Inc. | ANDA | Current |
| 11673-048 | Ibuprofen | Ibuprofen | TARGET Corporation | ANDA | Current |
| 11673-197 | Ibuprofen | IBUPROFEN | TARGET Corporation | ANDA | Current |
| 11673-197 | Ibuprofen | IBUPROFEN | TARGET Corporation | ANDA | Current |
| 11673-197 | Ibuprofen | IBUPROFEN | TARGET Corporation | ANDA | Current |
| 11822-0231 | Ibuprofen | Ibuprofen | Rite Aid Corporation | ANDA | Current |
| 11822-0231 | Ibuprofen | Ibuprofen | Rite Aid Corporation | ANDA | Current |
| 11822-0231 | Ibuprofen | Ibuprofen | Rite Aid Corporation | ANDA | Current |
| 11822-0589 | Ibuprofen | Ibuprofen | Rite Aid Corporation | ANDA | Current |
| 11822-0589 | Ibuprofen | Ibuprofen | Rite Aid Corporation | ANDA | Current |
| 11822-1879 | Dye-Free Ibuprofen | Ibuprofen | RITE AID CORPORATION | ANDA | Current |
| 11822-1879 | Dye-Free Ibuprofen | Ibuprofen | RITE AID CORPORATION | ANDA | Current |
| 11822-3307 | Ibuprofen | Ibuprofen | Rite Aid Corporation | ANDA | Current |
| 11822-3307 | Ibuprofen | Ibuprofen | Rite Aid Corporation | ANDA | Current |
| 11822-3307 | Ibuprofen | Ibuprofen | Rite Aid Corporation | ANDA | Current |
| 15127-316 | Ibuprofen | Ibuprofen | Select Brand Dist. | ANDA | Current |
| 15127-316 | Ibuprofen | Ibuprofen | Select Brand Dist. | ANDA | Current |
| 21130-197 | Ibuprofen | Ibuprofen | Safeway, Inc. | ANDA | Current |
| 21130-699 | Ibuprofen | Ibuprofen | Safeway, Inc. | ANDA | Current |
| 21130-699 | Ibuprofen | Ibuprofen | Safeway, Inc. | ANDA | Current |
| 24385-499 | Ibuprofen softgels | Ibuprofen | AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 | ANDA | Current |
| 24385-499 | Ibuprofen softgels | Ibuprofen | AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 | ANDA | Current |
| 27854-222 | Actrogel | Ibuprofen | Belmora LLC | ANDA | Current |
| 30142-048 | Ibuprofen | Ibuprofen | The Kroger Co. | ANDA | Current |
| 30142-048 | Ibuprofen | Ibuprofen | The Kroger Co. | ANDA | Current |
| 30142-048 | Ibuprofen | Ibuprofen | The Kroger Co. | ANDA | Current |
| 30142-053 | Ibuprofen | Ibuprofen | KROGER COMPANY | ANDA | Current |
| 30142-053 | Ibuprofen | Ibuprofen | KROGER COMPANY | ANDA | Current |
| 30142-053 | Ibuprofen | Ibuprofen | KROGER COMPANY | ANDA | Current |
| 30142-198 | Ibuprofen | IBUPROFEN | The Kroger Co. | ANDA | Current |
| 30142-198 | Ibuprofen | IBUPROFEN | The Kroger Co. | ANDA | Current |
| 33992-0199 | Ibuprofen | Ibuprofen | ASSURED / DOLLAR TREE (Greenbrier International, Inc.) | ANDA | Current |
| 33992-0199 | Ibuprofen | Ibuprofen | ASSURED / DOLLAR TREE (Greenbrier International, Inc.) | ANDA | Current |
| 36800-048 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-048 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-193 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-193 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-193 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-193 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-198 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-198 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-221 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 36800-221 | Ibuprofen | Ibuprofen | TOP CARE (Topco Associates LLC) | ANDA | Current |
| 37012-199 | Ibuprofen | Ibuprofen | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37205-736 | Ibuprofen | Ibuprofen | Cardinal Health (Leader) 37205 | ANDA | Current |
| 37205-736 | Ibuprofen | Ibuprofen | Cardinal Health (Leader) 37205 | ANDA | Current |
| 37205-736 | Ibuprofen | Ibuprofen | Cardinal Health (Leader) 37205 | ANDA | Current |
| 37808-198 | Ibuprofen | Ibuprofen | H E B | ANDA | Current |
| 37808-198 | Ibuprofen | Ibuprofen | H E B | ANDA | Current |
| 37808-198 | Ibuprofen | Ibuprofen | H E B | ANDA | Current |
| 37808-609 | Ibuprofen | Ibuprofen | HEB | ANDA | Current |
| 37808-609 | Ibuprofen | Ibuprofen | HEB | ANDA | Current |
| 37808-609 | Ibuprofen | Ibuprofen | HEB | ANDA | Current |
| 37808-699 | Ibuprofen | Ibuprofen | H E B | ANDA | Current |
| 41163-198 | Ibuprofen | Ibuprofen | EQUALINE (SuperValu) | ANDA | Current |
| 41163-198 | Ibuprofen | Ibuprofen | EQUALINE (SuperValu) | ANDA | Current |
| 41250-048 | Ibuprofen | Ibuprofen | MEIJER, INC. | ANDA | Current |
| 41250-048 | Ibuprofen | Ibuprofen | MEIJER, INC. | ANDA | Current |
| 41250-198 | Ibuprofen | Ibuprofen | MEIJER, INC. | ANDA | Current |
| 41250-198 | Ibuprofen | Ibuprofen | MEIJER, INC. | ANDA | Current |
| 41250-198 | Ibuprofen | Ibuprofen | MEIJER, INC. | ANDA | Current |
| 41250-286 | Ibuprofen | Ibuprofen | MEIJER DISTRIBUTION INC. | ANDA | Current |
| 41250-286 | Ibuprofen | Ibuprofen | MEIJER DISTRIBUTION INC. | ANDA | Current |