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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | caaa826d4ba7… | ||
| 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… |
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 |
|---|---|---|---|---|---|
| 59726-022 | Ibuprofen | IBUPROFEN | P & L Development, LLC | ANDA | Current |
| 59726-120 | Ibuprofen | Ibuprofen | PL Developments | ANDA | Current |
| 59726-199 | Ibuprofen | Ibuprofen | P & L Development, LLC | ANDA | Current |
| 59726-199 | Ibuprofen | Ibuprofen | P & L Development, LLC | ANDA | Current |
| 59779-108 | Ibuprofen | Ibuprofen | CVS Pharmacy | ANDA | Current |
| 59779-108 | Ibuprofen | Ibuprofen | CVS Pharmacy | ANDA | Current |
| 59779-197 | Ibuprofen | Ibuprofen | CVS Pharmacy | ANDA | Current |
| 59779-197 | Ibuprofen | Ibuprofen | CVS Pharmacy | ANDA | Current |
| 61715-054 | Ibuprofen | Ibuprofen | Preferred Plus (Kinray) | ANDA | Current |
| 61715-054 | Ibuprofen | Ibuprofen | Preferred Plus (Kinray) | ANDA | Current |
| 62011-0016 | IBUPROFEN | IBUPROFEN | McKesson (Health Mart) | ANDA | Current |
| 62011-0016 | IBUPROFEN | IBUPROFEN | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0016 | IBUPROFEN | IBUPROFEN | Strategic Sourcing Services LLC | ANDA | Current |
| 63868-427 | Ibuprofen | Ibuprofen | CHAIN DRUG MARKETING ASSOCIATION INC. | ANDA | Current |
| 63868-427 | Ibuprofen | Ibuprofen | CHAIN DRUG MARKETING ASSOCIATION INC. | ANDA | Current |
| 63868-428 | Ibuprofen | Ibuprofen | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA | Current |
| 63868-470 | Ibuprofen | Ibuprofen | Chain Drug Marketing Association, Inc. | ANDA | Current |
| 63868-470 | Ibuprofen | Ibuprofen | Chain Drug Marketing Association, Inc. | ANDA | Current |
| 63868-759 | Ibuprofen | Ibuprofen | QUALITY CHOICE (Chain Drug Marketing Association) | ANDA | Current |
| 63868-759 | Ibuprofen | Ibuprofen | QUALITY CHOICE (Chain Drug Marketing Association) | ANDA | Current |
| 63868-759 | Ibuprofen | Ibuprofen | QUALITY CHOICE (Chain Drug Marketing Association) | ANDA | Current |
| 63868-805 | Dye-Free Ibuprofen | Ibuprofen | CHAIN DRUG MARKETING ASSOCIATION INC. | ANDA | Current |
| 63868-805 | Dye-Free Ibuprofen | Ibuprofen | CHAIN DRUG MARKETING ASSOCIATION INC. | ANDA | Current |
| 63940-199 | Ibuprofen | IBUPROFEN | Harmon Stores | ANDA | Current |
| 63940-199 | Ibuprofen | IBUPROFEN | Harmon Stores | ANDA | Current |
| 63941-199 | Ibuprofen | Ibuprofen | Best Choice (Valu Merchandisers Company) | ANDA | Current |
| 63981-199 | Ibuprofen | IBUPROFEN | Costco Wholesale | ANDA | Current |
| 63981-199 | Ibuprofen | IBUPROFEN | Costco Wholesale | ANDA | Current |
| 63981-598 | Ibuprofen | IBUPROFEN | Costco Wholesale | ANDA | Current |
| 63981-598 | Ibuprofen | IBUPROFEN | Costco Wholesale | ANDA | Current |
| 63981-598 | Ibuprofen | IBUPROFEN | Costco Wholesale | ANDA | Current |
| 67091-141 | Ibuprofen | Ibuprofen | WinCo Foods, LLC | ANDA | Current |
| 67091-141 | Ibuprofen | Ibuprofen | WinCo Foods, LLC | ANDA | Current |
| 67091-141 | Ibuprofen | Ibuprofen | WinCo Foods, LLC | ANDA | Current |
| 68016-116 | Ibuprofen | Ibuprofen | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-116 | Ibuprofen | Ibuprofen | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-626 | Ibuprofen | Ibuprofen | Chain Drug Consortium, LLC | ANDA | Current |
| 68196-199 | Ibuprofen | Ibuprofen | Sam's West, Inc | ANDA | Current |
| 68196-199 | Ibuprofen | Ibuprofen | Sam's West, Inc | ANDA | Current |
| 68391-199 | Ibuprofen | Ibuprofen | BJWC (Berkley & Jensen / BJ's) | ANDA | Current |
| 68391-199 | Ibuprofen | Ibuprofen | BJWC (Berkley & Jensen / BJ's) | ANDA | Current |
| 68391-199 | Ibuprofen | Ibuprofen | BJWC (Berkley & Jensen / BJ's) | ANDA | Current |
| 68391-212 | Ibuprofen | Ibuprofen | BJWC | ANDA | Current |
| 68391-212 | Ibuprofen | Ibuprofen | BJWC | ANDA | Current |
| 69256-199 | Ibuprofen | IBUPROFEN | Harris Teeter, LLC | ANDA | Current |
| 69256-199 | Ibuprofen | IBUPROFEN | Harris Teeter, LLC | ANDA | Current |
| 69452-212 | Ibuprofen | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-212 | Ibuprofen | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-212 | Ibuprofen | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-239 | Ibuprofen | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-260 | pain relief | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-260 | pain relief | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-262 | pain relief | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-262 | pain relief | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-262 | pain relief | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-263 | Migraine Relief | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-263 | Migraine Relief | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-302 | dye-free pain relief | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-302 | dye-free pain relief | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-305 | Ibuprofen | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69452-305 | Ibuprofen | Ibuprofen | Bionpharma Inc. | ANDA | Current |
| 69842-892 | Ibuprofen Migraine | Ibuprofen | CVS Pharmacy | ANDA | Current |
| 69842-892 | Ibuprofen Migraine | Ibuprofen | CVS Pharmacy | ANDA | Current |
| 70000-0172 | Ibuprofen | Ibuprofen | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0172 | Ibuprofen | Ibuprofen | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0172 | Ibuprofen | Ibuprofen | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0197 | Ibuprofen | Ibuprofen | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0197 | Ibuprofen | Ibuprofen | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0197 | Ibuprofen | Ibuprofen | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0571 | Ibuprofen | Ibuprofen | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0571 | Ibuprofen | Ibuprofen | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70253-199 | Ibuprofen | IBUPROFEN | OUR FAMILY (Nash Finch Company) | ANDA | Current |
| 70469-199 | Ibuprofen | Ibuprofen | Capsule Corporation | ANDA | Current |
| 70469-199 | Ibuprofen | Ibuprofen | Capsule Corporation | ANDA | Current |
| 70677-0046 | Ibuprofen | Ibuprofen | Strategic Sourcing Services LLC | ANDA | Current |
| 70677-0046 | Ibuprofen | Ibuprofen | Strategic Sourcing Services LLC | ANDA | Current |
| 70677-0046 | Ibuprofen | Ibuprofen | Strategic Sourcing Services LLC | ANDA | Current |
| 70677-0046 | Ibuprofen | Ibuprofen | McKesson (Sunmark) | ANDA | Current |
| 82649-199 | Ibuprofen | IBUPROFEN | LifeMD | ANDA | Current |