Application 090796
- Type
- ANDA
- Sponsor
- MARKSANS PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 400MG | No | No |
| 002 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 600MG | No | No |
| 003 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 800MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090796-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | |
| A090796-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | |
| A090796-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090796-001 | AB |
| A090796-002 | AB |
| A090796-003 | AB |
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 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090796-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090796-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090796-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090796-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090796-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090796-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-001 | AB | 1 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 54b25106-5580-119d-e054-00144ff88e88 | 2024-07-17 | 090796 ANDA090796 | |
| IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 999aa615-72b2-9296-e053-2a95a90ac70b | 2024-06-20 | 090796 ANDA090796 | |
| IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 9973bfa2-693a-1165-e053-2995a90a4b1d | 2024-06-20 | 090796 ANDA090796 | |
| IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 99d7cf65-3ec2-24eb-e053-2a95a90acc5e | 2024-06-20 | 090796 ANDA090796 | |
| IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 6d86ce94-a06a-2769-e053-2991aa0afb95 | 2024-06-10 | 090796 ANDA090796 | |
| IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 6365b2d6-2337-70c0-e053-2a91aa0aa960 | 2024-06-06 | 090796 ANDA090796 | |
| ibuprofen | IBUPROFEN | SKYA HEALTH, LLC | 1c28af16-7246-4e4c-a1be-939655c37242 | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| IBUPROFEN | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 77adb094-869c-44b4-8a4e-b739ac9cd701 | 2021-04-20 | 090796 ANDA090796 | |
| ibuprofen | IBUPROFEN | Proficient Rx LP | 924d2dd0-3b7d-42ec-b617-86729dba2b95 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| IBUPROFEN | IBUPROFEN | Bryant Ranch Prepack | 6d189e86-4c36-43f5-b406-a342458d4155 | 2020-05-27 | 090796 ANDA090796 |
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 |
|---|---|---|---|---|---|
| 10544-201 | ibuprofen | ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-430 | ibuprofen | ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-431 | ibuprofen | ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-924 | ibuprofen | ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 25000-121 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-121 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-121 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-121 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-121 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-121 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-122 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-122 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-122 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-122 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-122 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-122 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-123 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-123 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-123 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-123 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-123 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-123 | Ibuprofen | Ibuprofen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 33358-187 | ibuprofen | ibuprofen | RxChange Co. | ANDA | Current |
| 42582-111 | Ibuprofen | Ibuprofen | Bi-Coastal Pharma International LLC | ANDA | Current |
| 42582-112 | Ibuprofen | Ibuprofen | Bi-Coastal Pharma International LLC | ANDA | Current |
| 42582-113 | Ibuprofen | Ibuprofen | Bi-Coastal Pharma International LLC | ANDA | Current |
| 42708-097 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 42708-097 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 42708-097 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 42708-097 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 42708-097 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 42708-097 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 43063-858 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-858 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-858 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-858 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-858 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-858 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-858 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-858 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-858 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-858 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-867 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-867 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-867 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-867 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-867 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-867 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-867 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-872 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-872 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-872 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-872 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-872 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-872 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-872 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-872 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-872 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-914 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-914 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-914 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-914 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-914 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-936 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-936 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-936 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-936 | IBUPROFEN | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 45865-117 | IBUPROFEN | IBUPROFEN | Medsource Pharmaceuticals | ANDA | Current |
| 45865-945 | IBUPROFEN | IBUPROFEN | medsource pharmaceuticals | ANDA | Current |
| 49483-602 | IBUPROFEN | IBUPROFEN | TIME CAP LABORATORIES, INC | ANDA | Current |
| 49483-602 | IBUPROFEN | IBUPROFEN | TIME CAP LABORATORIES, INC | ANDA | Current |
| 49483-603 | IBUPROFEN | IBUPROFEN | TIME CAP LABORATORIES, INC | ANDA | Current |
| 49483-603 | IBUPROFEN | IBUPROFEN | TIME CAP LABORATORIES, INC | ANDA | Current |
| 49483-604 | IBUPROFEN | IBUPROFEN | TIME CAP LABORATORIES, INC | ANDA | Current |
| 49483-604 | IBUPROFEN | IBUPROFEN | TIME CAP LABORATORIES, INC | ANDA | Current |
| 50090-5159 | IBUPROFEN | IBUPROFEN | A-S Medication Solutions | ANDA | Current |
| 50090-5159 | IBUPROFEN | IBUPROFEN | A-S Medication Solutions | ANDA | Current |
| 50090-5160 | IBUPROFEN | IBUPROFEN | A-S Medication Solutions | ANDA | Current |
| 50090-5160 | IBUPROFEN | IBUPROFEN | A-S Medication Solutions | ANDA | Current |
| 50090-5160 | IBUPROFEN | IBUPROFEN | A-S Medication Solutions | ANDA | Current |