Application 078558
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS NY
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 |
|---|---|---|---|---|---|---|---|
| A078558-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | |
| A078558-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | |
| A078558-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078558-001 | AB |
| A078558-002 | AB |
| A078558-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078558-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078558-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078558-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078558-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078558-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078558-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078558-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078558-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078558-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078558-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078558-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078558-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078558-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078558-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078558-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078558-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078558-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078558-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078558-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078558-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078558-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078558-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078558-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078558-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078558-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078558-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078558-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078558-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078558-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078558-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078558-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078558-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078558-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078558-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078558-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078558-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078558-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078558-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078558-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078558-001 | AB | 1 | 8072bd15b7f6… |
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 | Amneal Pharmaceuticals LLC | 17577b3b-e755-45d1-8b53-775d058578b2 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Cardinal Health 107, LLC | 0387bfaa-daca-48ec-b718-0216a848c16a | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | PHOENIX RX LLC | 40202c76-4275-88fd-e063-6394a90a07b2 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | American Health Packaging | e080f7da-a506-4c04-a227-c1be77234f01 | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 334e40f3-6da4-ecbe-e063-6294a90a35bf | 2025-04-21 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | fc871659-ce41-1be6-e053-6294a90aa5e4 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Advanced Rx of Tennessee, LLC | af9af7f4-6314-6217-e053-2995a90a5a0f | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Amneal Pharmaceuticals of New York LLC | faebc392-0fd9-4c71-8471-beba10dda022 | 2024-07-29 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 1a02fa34-b5ae-7183-e063-6294a90a3ae4 | 2024-06-03 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | e90c573d-eb0f-45a5-94d1-efdd3d2b7a11 | 2024-01-16 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | fa99f5ec-0306-473b-827f-86cd0a7978ec | 2023-08-31 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | e4bb22bb-6df6-4016-a023-0b454df9fb0b | 2023-06-01 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | e23eb275-ce0c-40ec-b809-a48c5e46c7ec | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-2525 | Ibuprofen | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-2526 | Ibuprofen | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-2528 | Ibuprofen | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10544-014 | Ibuprofen | Ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-015 | Ibuprofen | Ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-024 | Ibuprofen | Ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-030 | Ibuprofen | Ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-213 | Ibuprofen | Ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-214 | Ibuprofen | Ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-613 | Ibuprofen | Ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 11819-357 | Ibuprofen | Ibuprofen | HHS/Program Support Center/Supply Service Center | ANDA | Current |
| 33261-061 | Ibuprofen | Ibuprofen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-062 | Ibuprofen | Ibuprofen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-155 | Ibuprofen | Ibuprofen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33358-188 | Ibuprofen | Ibuprofen | RxChange Co. | ANDA | Current |
| 35356-698 | Ibuprofen | Ibuprofen | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | ANDA | Current |
| 42254-034 | Ibuprofen | Ibuprofen | Rebel Distributors Corp | ANDA | Current |
| 42254-063 | Ibuprofen | Ibuprofen | Rebel Distributors Corp | ANDA | Current |
| 42254-089 | Ibuprofen | Ibuprofen | Rebel Distributors Corp | ANDA | Current |
| 42291-337 | Ibuprofen | Ibuprofen | AvKARE, Inc. | ANDA | Current |
| 42291-337 | Ibuprofen | Ibuprofen | AvKARE, Inc. | ANDA | Current |
| 42291-337 | Ibuprofen | Ibuprofen | AvKARE, Inc. | ANDA | Current |
| 42291-337 | Ibuprofen | Ibuprofen | AvKARE, Inc. | ANDA | Current |
| 42291-338 | Ibuprofen | Ibuprofen | AvKARE, Inc. | ANDA | Current |
| 42291-338 | Ibuprofen | Ibuprofen | AvKARE, Inc. | ANDA | Current |
| 42291-338 | Ibuprofen | Ibuprofen | AvKARE, Inc. | ANDA | Current |
| 42291-338 | Ibuprofen | Ibuprofen | AvKARE, Inc. | ANDA | Current |
| 42291-339 | Ibuprofen | Ibuprofen | AvKARE, Inc. | ANDA | Current |
| 42291-339 | Ibuprofen | Ibuprofen | AvKARE, Inc. | ANDA | Current |
| 42291-339 | Ibuprofen | Ibuprofen | AvKARE, Inc. | ANDA | Current |
| 42291-339 | Ibuprofen | Ibuprofen | AvKARE, Inc. | ANDA | Current |
| 42708-029 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 42708-057 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 42708-057 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 43063-013 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-013 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-013 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-013 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-308 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-308 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-352 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-352 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-352 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-352 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-352 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-843 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-843 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-843 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-843 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-843 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-843 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-845 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-845 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-845 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-845 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-845 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-845 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-847 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-847 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-847 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-847 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-847 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-847 | Ibuprofen | Ibuprofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-389 | Ibuprofen | Ibuprofen | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 43353-389 | Ibuprofen | Ibuprofen | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 43353-391 | Ibuprofen | Ibuprofen | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 43353-391 | Ibuprofen | Ibuprofen | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 43353-393 | Ibuprofen | Ibuprofen | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 43353-393 | Ibuprofen | Ibuprofen | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 45865-373 | Ibuprofen | Ibuprofen | Medsource Pharmaceuticals | ANDA | Current |
| 45865-474 | Ibuprofen | Ibuprofen | Medsource Pharmaceuticals | ANDA | Current |
| 45865-474 | Ibuprofen | Ibuprofen | Medsource Pharmaceuticals | ANDA | Current |
| 49999-006 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-0060 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-0066 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2751 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-4367 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50436-4606 | Ibuprofen | Ibuprofen | Unit Dose Services | ANDA | Current |
| 51138-039 | Ibuprofen | Ibuprofen | Med Health Pharma, LLC | ANDA | Current |
| 51655-035 | Ibuprofen | Ibuprofen | Northwind Pharmaceuticals, LLC | ANDA | Current |