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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090796-001 | AB | 1 | 1e350fbaab3a… |
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 | REMEDYREPACK INC. | a7756b22-73cf-4262-aa8e-0577ddecd03b | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| IBUPROFEN | IBUPROFEN | St. Mary's Medical Park Pharmacy | 950c3ca7-4481-976f-e053-2995a90ad51e | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 60760-604 |
| IBUPROFEN | IBUPROFEN | St. Mary's Medical Park Pharmacy | 95830141-2439-9d45-e053-2995a90ae084 | 2026-05-01 | 090796 ANDA090796 60760-603 | |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | a348a959-46bc-4ff6-8936-12866fc34a4b | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | Northwind Health Company, LLC | c20f1f4d-59b3-6bbe-e053-2a95a90abaf1 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 51655-275 |
| Ibuprofen | IBUPROFEN | Northwind Health Company, LLC | dac07d8f-6b6f-20ab-e053-2a95a90af3ba | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | Northwind Health Company, LLC | da6c72ad-009f-3d7f-e053-2995a90a68e9 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | QPharma, Inc. | f452d2c3-525f-4933-b146-92351d0ae44f | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ce5b0429-bbe1-47a4-af5e-0159d3cfd2c3 | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| IBUPROFEN | IBUPROFEN | Direct Rx | d88d0544-57a7-4a82-e053-2a95a90a1945 | 2025-01-21 | 090796 ANDA090796 | |
| IBUPROFEN | IBUPROFEN | DIRECT RX | c3f30813-0848-6e8a-e053-2995a90a3dea | 2025-01-20 | 090796 ANDA090796 | |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 7546e868-d99f-4f8c-b1e9-cc96fd9fa1eb | 2025-01-13 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 701ee488-c57f-a82c-e053-2991aa0af403 | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 9b02607a-6fab-5205-e053-2a95a90afa26 | 2025-01-02 | 090796 ANDA090796 68071-5140 | |
| Ibuprofen | IBUPROFEN | Advanced Rx of Tennessee, LLC | b33caad1-8d40-16f2-e053-2a95a90a1b2d | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | Advanced Rx Pharmacy of Tennessee, LLC | bd1ca7af-d640-23fb-e053-2a95a90a8a98 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | Advanced Rx Pharmacy of Tennessee, LLC | f18b6a0a-e42f-083d-e053-2995a90a40e4 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | TIME CAP LABORATORIES, INC | ec3e8443-d742-4c25-8516-f0df4ebfccdc | 2024-11-21 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | MARKSANS PHARMA LIMITED | e54209c2-f726-440b-ac60-5a72710d2a9b | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | Advanced Rx of Tennessee, LLC | 19b06eaf-0d4c-2b4d-e063-6294a90a2eb9 | 2024-08-06 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50436-0296 | ibuprofen | ibuprofen | Unit Dose Services | ANDA | Current |
| 51655-050 | Ibuprofen | Ibuprofen | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-275 | IBUPROFEN | IBUPROFEN | Northwind Pharmaceuticals | ANDA | Current |
| 52605-121 | Ibuprofen | Ibuprofen | Polygen Pharmaceuticals LLC | ANDA | Current |
| 52605-122 | Ibuprofen | Ibuprofen | Polygen Pharmaceuticals LLC | ANDA | Current |
| 52605-123 | Ibuprofen | Ibuprofen | Polygen Pharmaceuticals LLC | ANDA | Current |
| 53002-3011 | IBUPROFEN | IBUPROFEN | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3372 | IBUPROFEN | IBUPROFEN | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-167 | ibuprofen | ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-168 | ibuprofen | ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60760-603 | IBUPROFEN | IBUPROFEN | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-603 | IBUPROFEN | IBUPROFEN | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-603 | IBUPROFEN | IBUPROFEN | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-603 | IBUPROFEN | IBUPROFEN | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-604 | IBUPROFEN | IBUPROFEN | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-604 | IBUPROFEN | IBUPROFEN | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-604 | IBUPROFEN | IBUPROFEN | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-604 | IBUPROFEN | IBUPROFEN | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61786-947 | IBUPROFEN | IBUPROFEN | REMEDYREPACK INC. | ANDA | Current |
| 63187-451 | ibuprofen | ibuprofen | Proficient Rx LP | ANDA | Current |
| 63187-451 | ibuprofen | ibuprofen | Proficient Rx LP | ANDA | Current |
| 67046-306 | ibuprofen | ibuprofen | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-314 | ibuprofen | ibuprofen | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-688 | Ibuprofen | Ibuprofen | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1339 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1339 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1584 | IBUPROFEN | IBUPROFEN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1584 | IBUPROFEN | IBUPROFEN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1584 | IBUPROFEN | IBUPROFEN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1584 | IBUPROFEN | IBUPROFEN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1685 | IBUPROFEN | IBUPROFEN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1685 | IBUPROFEN | IBUPROFEN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1756 | IBUPROFEN | IBUPROFEN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1756 | IBUPROFEN | IBUPROFEN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1756 | IBUPROFEN | IBUPROFEN | RedPharm Drug, Inc. | ANDA | Current |
| 67877-294 | ibuprofen | ibuprofen | Ascend Laboratories, LLC | ANDA | Current |
| 67877-295 | ibuprofen | ibuprofen | Ascend Laboratories, LLC | ANDA | Current |
| 67877-295 | ibuprofen | ibuprofen | Ascend Laboratories, LLC | ANDA | Current |
| 67877-296 | ibuprofen | ibuprofen | Ascend Laboratories, LLC | ANDA | Current |
| 68071-3362 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3362 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3362 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3362 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4009 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4009 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4009 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4243 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4243 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4243 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4459 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4459 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5126 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5126 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5126 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5134 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5134 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5135 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5135 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5140 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5140 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5140 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5140 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5154 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5154 | IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7079 | IBUPROFEN | IBUPROFEN | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7079 | IBUPROFEN | IBUPROFEN | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7079 | IBUPROFEN | IBUPROFEN | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7602 | IBUPROFEN | IBUPROFEN | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7602 | IBUPROFEN | IBUPROFEN | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7602 | IBUPROFEN | IBUPROFEN | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7745 | IBUPROFEN | IBUPROFEN | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7745 | IBUPROFEN | IBUPROFEN | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7745 | IBUPROFEN | IBUPROFEN | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9739 | ibuprofen | ibuprofen | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9740 | ibuprofen | ibuprofen | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9741 | ibuprofen | ibuprofen | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0005 | IBUPROFEN | IBUPROFEN | REMEDYREPACK INC. | ANDA | Current |
| 70518-0005 | IBUPROFEN | IBUPROFEN | REMEDYREPACK INC. | ANDA | Current |
| 70518-0005 | IBUPROFEN | IBUPROFEN | REMEDYREPACK INC. | ANDA | Current |
| 70518-0005 | IBUPROFEN | IBUPROFEN | REMEDYREPACK INC. | ANDA | Current |