Application 075682
- Type
- ANDA
- Sponsor
- DR REDDYS LA
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 | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075682-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | |
| A075682-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | |
| A075682-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075682-001 | AB |
| A075682-002 | AB |
| A075682-003 | 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 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075682-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2001-11-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075682-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | RS | 2001-11-14 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075682-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2001-11-14 | 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 | A075682-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075682-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075682-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075682-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075682-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075682-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075682-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075682-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075682-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075682-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075682-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075682-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075682-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075682-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075682-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075682-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075682-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075682-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075682-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075682-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075682-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075682-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075682-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075682-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075682-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075682-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075682-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075682-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075682-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075682-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075682-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075682-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075682-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075682-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075682-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075682-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075682-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075682-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075682-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075682-001 | 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 | Preferred Pharmaceuticals, Inc. | 72ec2491-924d-460f-9510-62d624d54b59 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | Golden State Medical Supply, Inc. | bbf4821d-f9fc-9f6e-e053-2a95a90a5253 | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 51407-371 51407-370 51407-369 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 4522b794-5c93-44cd-e063-6394a90ab39a | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 45223597-0ea8-b275-e063-6394a90a8412 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 4522cb9e-4999-c455-e063-6294a90a294f | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | Proficient Rx LP | a7098fa1-b5ae-485e-ada9-64154f81fb6a | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Golden State Medical Supply, Inc. | 3ff501eb-5ae3-8824-e063-6394a90ac58e | 2025-11-19 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Major Pharmaceuticals | ba86e936-ef72-43e5-aebf-f2c788fe2266 | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 0904-5853 0904-5855 0904-5854 |
| Ibuprofen | IBUPROFEN | Cardinal Health 107, LLC | 8ea0e303-3967-4d71-8255-ac42a841ce28 | 2025-08-08 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 55154-1380 55154-1342 55154-0741 |
| IBU | IBUPROFEN | Dr. Reddy's Laboratories Limited | 24731405-219c-79b4-ecf0-7d5fbfda94ba | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 55111-682 55111-683 55111-684 |
| IBU | IBU | RedPharm Drug, Inc. | 4db219dc-ea48-490c-e054-00144ff88e88 | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 31e6005b-492e-7936-e063-6394a90ad801 | 2025-04-03 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 31e6ac7a-fa3e-4dd4-e063-6294a90a29af | 2025-04-03 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 7650f84b-92f2-4065-8ef2-f5de5bd7002b | 2024-10-29 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 593d9870-0213-75e6-e053-2991aa0a0eff | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | NuCare Pharmaceuticals Inc. | 575c275c-3e1a-0572-e053-2991aa0adabd | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 678e2d16-33f3-67a7-e053-2991aa0a1132 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | Proficient Rx LP | ea6f626d-cda3-46e2-9ac9-4e72204cb726 | 2023-03-01 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | b0f03994-b744-4d66-95b7-8c86217882bc | 2021-05-24 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
| IBU | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd | 2021-01-21 | Boxed warning, Warnings, Adverse reactions | 075682 ANDA075682 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8115 | IBU | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8115 | IBU | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8116 | IBU | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8116 | IBU | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8117 | IBU | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8117 | IBU | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-5853 | Ibuprofen | Ibuprofen | Major Pharmaceuticals | ANDA | Current |
| 0904-5853 | Ibuprofen | Ibuprofen | Major Pharmaceuticals | ANDA | Current |
| 0904-5854 | Ibuprofen | Ibuprofen | Major Pharmaceuticals | ANDA | Current |
| 0904-5854 | Ibuprofen | Ibuprofen | Major Pharmaceuticals | ANDA | Current |
| 0904-5855 | Ibuprofen | Ibuprofen | Major Pharmaceuticals | ANDA | Current |
| 0904-5855 | Ibuprofen | Ibuprofen | Major Pharmaceuticals | ANDA | Current |
| 10544-071 | IBU | Ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-625 | IBU | Ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 12634-171 | IBUPROFEN | Ibuprofen | Apotheca Inc. | ANDA | Current |
| 12634-191 | IBUPROFEN | Ibuprofen | Apotheca Inc. | ANDA | Current |
| 12634-682 | IBUPROFEN | Ibuprofen | Apotheca Inc. | ANDA | Current |
| 21695-066 | Ibuprofen | Ibuprofen | Rebel Distributors Corp | ANDA | Current |
| 21695-067 | Ibuprofen | Ibuprofen | Rebel Distributors Corp | ANDA | Current |
| 21695-068 | Ibuprofen | Ibuprofen | Rebel Distributors Corp | ANDA | Current |
| 35356-699 | IBU | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-699 | IBU | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 43353-095 | Ibuprofen | Ibuprofen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-095 | Ibuprofen | Ibuprofen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-273 | IBU | Ibuprofen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-314 | Ibuprofen | Ibuprofen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-314 | Ibuprofen | Ibuprofen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-4331 | IBU | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-4333 | IBU | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-4339 | IBU | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-4341 | IBU | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50436-0684 | IBU | Ibuprofen | Unit Dose Services | ANDA | Current |
| 50436-4604 | IBU | Ibuprofen | Unit Dose Services | ANDA | Current |
| 50436-4605 | IBU | Ibuprofen | Unit Dose Services | ANDA | Current |
| 51407-369 | IBU | Ibuprofen | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-370 | IBU | Ibuprofen | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-371 | IBU | Ibuprofen | Golden State Medical Supply, Inc. | ANDA | Current |
| 51655-851 | Ibuprofen | Ibuprofen | Northwind Pharmaceuticals | ANDA | Current |
| 53002-3010 | IBU | Ibuprofen | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3010 | IBU | Ibuprofen | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3370 | IBU | Ibuprofen | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3370 | IBU | Ibuprofen | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3980 | IBU | Ibuprofen | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3980 | IBU | Ibuprofen | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-366 | IBU | Ibuprofen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55111-682 | IBU | Ibuprofen | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-682 | IBU | Ibuprofen | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-683 | IBU | Ibuprofen | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-683 | IBU | Ibuprofen | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-684 | IBU | Ibuprofen | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-684 | IBU | Ibuprofen | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55154-0741 | Ibuprofen | Ibuprofen | Cardinal Health | ANDA | Current |
| 55154-0741 | Ibuprofen | Ibuprofen | Cardinal Health 107, LLC | ANDA | Current |
| 55154-0741 | Ibuprofen | Ibuprofen | Cardinal Health | ANDA | Current |
| 55154-0741 | Ibuprofen | Ibuprofen | Cardinal Health | ANDA | Current |
| 55154-1342 | Ibuprofen | Ibuprofen | Cardinal Health | ANDA | Current |
| 55154-1342 | Ibuprofen | Ibuprofen | Cardinal Health 107, LLC | ANDA | Current |
| 55154-1342 | Ibuprofen | Ibuprofen | Cardinal Health | ANDA | Current |
| 55154-1342 | Ibuprofen | Ibuprofen | Cardinal Health | ANDA | Current |
| 55154-1380 | Ibuprofen | Ibuprofen | Cardinal Health | ANDA | Current |
| 55154-1380 | Ibuprofen | Ibuprofen | Cardinal Health 107, LLC | ANDA | Current |
| 55154-1380 | Ibuprofen | Ibuprofen | Cardinal Health | ANDA | Current |
| 55154-1380 | Ibuprofen | Ibuprofen | Cardinal Health | ANDA | Current |
| 59088-703 | PharmapureRx IBU 600-EZS | ibuprofen | PureTek Corporation | ANDA | Current |
| 60429-219 | IBU | Ibuprofen | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-219 | IBU | Ibuprofen | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-220 | IBU | Ibuprofen | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-220 | IBU | Ibuprofen | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-221 | IBU | Ibuprofen | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-221 | IBU | Ibuprofen | Golden State Medical Supply, Inc. | ANDA | Current |
| 60760-076 | IBU | Ibuprofen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-076 | IBU | Ibuprofen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-135 | IBU | Ibuprofen | St. Mary | ANDA | Current |
| 61919-621 | IBU | IBU | DirectRX | ANDA | Current |
| 61919-621 | IBU | IBU | DIRECT RX | ANDA | Current |
| 61919-621 | IBU | IBU | DirectRX | ANDA | Current |
| 61919-621 | IBU | IBU | DirectRX | ANDA | Current |
| 61919-621 | IBU | IBU | Direct_Rx | ANDA | Current |
| 61919-621 | IBU | IBU | Direct_Rx | ANDA | Current |
| 61919-621 | IBU | IBU | Direct_Rx | ANDA | Current |