Application 214836
- Type
- ANDA
- Sponsor
- L PERRIGO CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAMINOPHEN AND IBUPROFEN | ACETAMINOPHEN; IBUPROFEN | TABLET;ORAL | 250MG;125MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214836-001 | ACETAMINOPHEN AND IBUPROFEN | ACETAMINOPHEN; IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 |
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 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | 053a50430f4f… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214836-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-02-28 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| equate dual back pain reliever | ACETAMINOPHEN, IBUPROFEN | WALMART INC. | af7e6478-177f-473d-9d14-1e78610b1a6e | 2025-05-17 | Warnings | 214836 ANDA214836 |
| Good Sense Dual Action Back Pain | ACETAMINOPHEN, IBUPROFEN | L. Perrigo Company | 89476188-cf88-4184-a366-ed4c2e7db145 | 2024-03-19 | Warnings | 214836 ANDA214836 |
| Basic Care Dual Action | ACETAMINOPHEN, IBUPROFEN | Amazon.com Services LLC | 7e27f5cb-8728-400f-82c5-0984276aa5dd | 2024-02-20 | Warnings | 214836 ANDA214836 |
| Topcare Dual Action Back Pain | ACETAMINOPHEN, IBUPROFEN | Topco Associates LLC | e40ec21c-6c44-4219-a94f-8b93a4853aa5 | 2024-02-06 | Warnings | 214836 ANDA214836 |
| DG health dual pain reliever | ACETAMINOPHEN, IBUPROFEN | Dolgencorp Inc | 464d436a-79b0-45b4-8b5f-51dc2de2d8e4 | 2023-05-19 | Warnings | 214836 ANDA214836 |
| equate pain reliever | ACETAMINOPHEN, IBUPROFEN | WALMART INC. | 8e0aaae0-a97d-4b9d-b326-44ef45f3fa0c | 2023-03-17 | Warnings | 214836 ANDA214836 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73755 | ORIG | 2023-03-14 |