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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078682-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2009-03-24 | 84e616aacf4f… | ||
| 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… |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 41250-292 | Ibuprofen | Ibuprofen | MEIJER DISTRIBUTION INC. | ANDA | Current |
| 41250-292 | Ibuprofen | Ibuprofen | MEIJER DISTRIBUTION INC. | ANDA | Current |
| 41250-293 | Ibuprofen | Ibuprofen | MEIJER DISTRIBUTION INC. | ANDA | Current |
| 41250-293 | Ibuprofen | Ibuprofen | MEIJER DISTRIBUTION INC. | ANDA | Current |
| 41520-195 | Ibuprofen | Ibuprofen | Care One (American Sales Company) | ANDA | Current |
| 41520-195 | Ibuprofen | Ibuprofen | Care One (American Sales Company) | ANDA | Current |
| 42507-131 | Ibuprofen | Ibuprofen | Hy-Vee | ANDA | Current |
| 42507-131 | Ibuprofen | Ibuprofen | Hy-Vee | ANDA | Current |
| 42507-131 | Ibuprofen | Ibuprofen | Hy-Vee | ANDA | Current |
| 42507-198 | Ibuprofen | Ibuprofen | Hy-Vee | ANDA | Current |
| 42507-198 | Ibuprofen | Ibuprofen | Hy-Vee | ANDA | Current |
| 42507-198 | Ibuprofen | Ibuprofen | Hy-Vee | ANDA | Current |
| 42507-408 | Ibuprofen | Ibuprofen | Hy-Vee | ANDA | Current |
| 42507-408 | Ibuprofen | Ibuprofen | Hy-Vee | ANDA | Current |
| 42507-408 | Ibuprofen | Ibuprofen | Hy-Vee | ANDA | Current |
| 46122-580 | Ibuprofen | Ibuprofen | AMERISOURCE BERGEN | ANDA | Current |
| 46122-580 | Ibuprofen | Ibuprofen | AMERISOURCE BERGEN | ANDA | Current |
| 46122-580 | Ibuprofen | Ibuprofen | AMERISOURCE BERGEN | ANDA | Current |
| 46122-593 | Ibuprofen | Ibuprofen | AMERISOURCE BERGEN | ANDA | Current |
| 46122-593 | Ibuprofen | Ibuprofen | AMERISOURCE BERGEN | ANDA | Current |
| 46122-593 | Ibuprofen | Ibuprofen | AMERISOURCE BERGEN | ANDA | Current |
| 49035-198 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-198 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-198 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-228 | Ibuprofen | Ibuprofen | Wal-Mart Stores, Inc | ANDA | Current |
| 49035-381 | Ibuprofen | Ibuprofen | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-381 | Ibuprofen | Ibuprofen | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-381 | Ibuprofen | Ibuprofen | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-408 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-408 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-408 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | ANDA | Current |
| 49035-598 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-598 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-598 | Ibuprofen | Ibuprofen | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49348-568 | Ibuprofen | Ibuprofen | McKesson (Sunmark) | ANDA | Current |
| 49738-198 | Ibuprofen | Ibuprofen | SMART SENSE (Kmart) | ANDA | Current |
| 49738-198 | Ibuprofen | Ibuprofen | SMART SENSE (Kmart) | ANDA | Current |
| 49738-198 | Ibuprofen | Ibuprofen | SMART SENSE (Kmart) | ANDA | Current |
| 50580-120 | Motrin IB Migraine | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
| 50580-409 | Motrin IB | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
| 50580-409 | Motrin IB | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
| 50580-409 | Motrin IB | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
| 50580-409 | Motrin IB | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
| 50804-199 | Ibuprofen | Ibuprofen | Good Sense (Geiss, Destin & Dunn, Inc.) | ANDA | Current |
| 50804-199 | Ibuprofen | Ibuprofen | Good Sense (Geiss, Destin & Dunn, Inc.) | ANDA | Current |
| 50804-199 | Ibuprofen | Ibuprofen | Good Sense (Geiss, Destin & Dunn, Inc.) | ANDA | Current |
| 50804-199 | Ibuprofen | Ibuprofen | Good Sense (Geiss, Destin & Dunn, Inc.) | ANDA | Current |
| 50804-199 | Ibuprofen | Ibuprofen | Good Sense (Geiss, Destin & Dunn, Inc.) | ANDA | Current |
| 50804-199 | Ibuprofen | Ibuprofen | Good Sense (Geiss, Destin & Dunn, Inc.) | ANDA | Current |
| 50844-754 | Ibuprofen | Ibuprofen | L.N.K. International, Inc. | ANDA | Current |
| 50844-754 | Ibuprofen | Ibuprofen | L.N.K. International, Inc. | ANDA | Current |
| 50844-754 | Ibuprofen | Ibuprofen | L.N.K. International, Inc. | ANDA | Current |
| 53187-199 | Ibuprofen | Ibuprofen | LIVE BETTER (The Great Atlantic & Pacific Tea Company) | ANDA | Current |
| 53187-199 | Ibuprofen | Ibuprofen | LIVE BETTER (The Great Atlantic & Pacific Tea Company) | ANDA | Current |
| 53187-199 | Ibuprofen | Ibuprofen | LIVE BETTER (The Great Atlantic & Pacific Tea Company) | ANDA | Current |
| 53943-212 | IBUPROFEN | Ibuprofen | DISCOUNT DRUG MART, INC. | ANDA | Current |
| 53943-212 | IBUPROFEN | Ibuprofen | DISCOUNT DRUG MART, INC. | ANDA | Current |
| 53943-214 | Ibuprofen | Ibuprofen | DISCOUNT DRUG MART, INC. | ANDA | Current |
| 53943-214 | Ibuprofen | Ibuprofen | DISCOUNT DRUG MART, INC. | ANDA | Current |
| 55301-199 | Ibuprofen | Ibuprofen | AAFES/Your Military Exchanges | ANDA | Current |
| 55301-199 | Ibuprofen | Ibuprofen | AAFES/Your Military Exchanges | ANDA | Current |
| 55301-199 | Ibuprofen | Ibuprofen | AAFES/Your Military Exchanges | ANDA | Current |
| 55312-197 | Ibuprofen | Ibuprofen | Western Family Foods, Inc. | ANDA | Current |
| 55315-199 | Ibuprofen | Ibuprofen | Freds Inc | ANDA | Current |
| 55316-131 | Ibuprofen | Ibuprofen | Healthy Accents (DZA Brands, LLC) | ANDA | Current |
| 55316-131 | Ibuprofen | Ibuprofen | Healthy Accents (DZA Brands, LLC) | ANDA | Current |
| 55316-198 | Ibuprofen | Ibuprofen | Healthy Accents (DZA Brands, LLC) | ANDA | Current |
| 55316-198 | Ibuprofen | Ibuprofen | Healthy Accents (DZA Brands, LLC) | ANDA | Current |
| 55319-199 | Ibuprofen | Ibuprofen | Family Dollar (FAMILY WELLNESS) | ANDA | Current |
| 55319-199 | Ibuprofen | Ibuprofen | Family Dollar (FAMILY WELLNESS) | ANDA | Current |
| 55319-199 | Ibuprofen | Ibuprofen | Family Dollar (FAMILY WELLNESS) | ANDA | Current |
| 55910-197 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-197 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-197 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-199 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-408 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-408 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-408 | Ibuprofen | Ibuprofen | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 56062-199 | Ibuprofen | IBUPROFEN | Publix Supermarkets, Inc. | ANDA | Current |
| 56062-199 | Ibuprofen | IBUPROFEN | Publix Supermarkets, Inc. | ANDA | Current |