Application 202413
- Type
- ANDA
- Sponsor
- SHANDONG XINHUA
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 |
| 004 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202413-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | |
| A202413-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | |
| A202413-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | |
| A202413-004 | IBUPROFEN | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202413-001 | AB |
| A202413-002 | AB |
| A202413-003 | 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 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202413-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202413-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202413-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202413-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202413-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202413-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202413-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202413-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202413-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202413-001 | 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 | Redpharm Drug | 44f609dd-c868-493f-e063-6294a90a7138 | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 71b5b2a2-397e-4dcb-b0c7-ef08df4337e0 | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 47711610-6577-4805-a2ce-cf9b7cbfa812 | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Advanced Rx of Tennessee, LLC | 41351cc0-5ec6-2f4d-e063-6294a90a733a | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Coupler LLC | 410f7320-4caa-8f88-e063-6394a90acf93 | 2025-10-13 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | a85080d7-50b4-461b-9d77-d6fbab971c03 | 2025-10-13 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | PHOENIX RX LLC | 3b17587e-b609-42a9-e063-6294a90ab1f8 | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | SOLA Pharmaceuticals, LLC | 44fb0842-c34e-477e-96df-350cd5d6800e | 2025-07-20 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 388e68dc-1822-f375-e063-6294a90a3d41 | 2025-06-27 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals, Inc. | 2c3f8149-9b77-54cd-e063-6394a90a847e | 2025-05-21 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals, Inc. | 3520deb7-5e45-3d0f-e063-6394a90ab44b | 2025-05-14 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 34673d3b-41cd-f4c9-e063-6394a90a8510 | 2025-05-05 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 3467b45b-c432-2923-e063-6394a90a1044 | 2025-05-05 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Brisk Pharmaceuticals | 2dcbe4bb-fb24-e827-e063-6394a90acf9f | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 2d0c2d35-c212-4daa-b2c4-b407ca0b16ad | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 2b470e48-c23c-4f5c-916a-d38d8518896b | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | df0e55d0-617c-4084-984f-ece2f640e715 | 2024-10-11 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | b0917020-f0ec-4d07-8fbf-c1eb909f466b | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | b365be3a-91ad-46bf-a949-103c81f2359a | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Westminster Pharmaceuticals, LLC | eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
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 |
|---|---|---|---|---|---|
| 11788-008 | ibuprofen | ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-008 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-008 | ibuprofen | ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-008 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-008 | ibuprofen | ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-008 | ibuprofen | ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-008 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-008 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-008 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-008 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-009 | ibuprofen | ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-009 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-009 | ibuprofen | ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-009 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-009 | ibuprofen | ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-009 | ibuprofen | ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-009 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-009 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-009 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-009 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-010 | ibuprofen | ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-010 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-010 | ibuprofen | ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-010 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-010 | ibuprofen | ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-010 | ibuprofen | ibuprofen | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-010 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-010 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-010 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 11788-010 | ibuprofen | ibuprofen | AiPing Pharmaceutical Inc. | ANDA | Current |
| 50090-4228 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-4230 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 51293-843 | ibuprofen | ibuprofen | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-843 | ibuprofen | ibuprofen | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-844 | ibuprofen | ibuprofen | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-844 | ibuprofen | ibuprofen | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-845 | ibuprofen | ibuprofen | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-845 | ibuprofen | ibuprofen | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 55700-633 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-633 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-634 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-634 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 58657-680 | Ibuprofen | Ibuprofen | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-680 | Ibuprofen | Ibuprofen | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-681 | Ibuprofen | Ibuprofen | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-681 | Ibuprofen | Ibuprofen | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-682 | Ibuprofen | Ibuprofen | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-682 | Ibuprofen | Ibuprofen | Method Pharmaceuticals, LLC | ANDA | Current |
| 62135-400 | Ibuprofen | Ibuprofen | Chartwell RX, LLC | ANDA | Current |
| 62135-400 | Ibuprofen | Ibuprofen | Chartwell RX, LLC | ANDA | Current |
| 62135-401 | Ibuprofen | Ibuprofen | Chartwell RX, LLC | ANDA | Current |
| 62135-401 | Ibuprofen | Ibuprofen | Chartwell RX, LLC | ANDA | Current |
| 62135-402 | Ibuprofen | Ibuprofen | Chartwell RX, LLC | ANDA | Current |
| 62135-402 | Ibuprofen | Ibuprofen | Chartwell RX, LLC | ANDA | Current |
| 67296-1573 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1573 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1633 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1633 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1634 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1634 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
| 68788-8182 | ibuprofen | ibuprofen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8183 | ibuprofen | ibuprofen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2902 | ibuprofen | ibuprofen | REMEDYREPACK INC. | ANDA | Current |
| 70518-2902 | ibuprofen | ibuprofen | REMEDYREPACK INC. | ANDA | Current |
| 70518-3016 | ibuprofen | ibuprofen | REMEDYREPACK INC. | ANDA | Current |
| 71335-1177 | Ibuprofen | Ibuprofen | Bryant Ranch Prepack | ANDA | Current |
| 71610-456 | ibuprofen | ibuprofen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71862-003 | Ibuprofen | Ibuprofen | Landmark Supply Inc. | ANDA | Current |
| 71862-003 | Ibuprofen | Ibuprofen | Landmark Supply Inc. | ANDA | Current |
| 71862-007 | Ibuprofen | Ibuprofen | Landmark Supply Inc. | ANDA | Current |
| 71862-007 | Ibuprofen | Ibuprofen | Landmark Supply Inc. | ANDA | Current |