Application 078329
- Type
- ANDA
- Sponsor
- STRIDES 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 |
|---|---|---|---|---|---|---|---|
| A078329-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | |
| A078329-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | |
| A078329-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078329-001 | AB |
| A078329-002 | AB |
| A078329-003 | 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 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 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 | A078329-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078329-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078329-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078329-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078329-001 | 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 | St. Mary's Medical Park Pharmacy | 88dd304f-1c64-08e3-e053-2a95a90a596f | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 60760-596 |
| Ibuprofen | IBUPROFEN | ST. MARY'S MEDICAL PARK PHARMACY | 88dda062-2b9c-3632-e053-2a95a90a1431 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 60760-597 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | 60c731c6-4dc4-490a-8469-0b7e58e563a1 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 1ebf94fb-76b6-4c01-be1b-575062827545 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 0550fa2f-f25e-4abb-b10e-a3d05bdb3217 | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | c38a03fa-6b9a-4737-a848-063ca5c580b9 | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 8dba0ed8-feef-23a5-e053-2995a90aaff8 | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Strides Pharma Science Limited | a266a3c6-932f-476f-ae93-48a785c92286 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 64380-807 64380-809 64380-808 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 86577bf3-51c6-88e2-e053-2991aa0ac741 | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Direct_Rx | 40071818-5bf0-095b-e063-6294a90ad58a | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | 06710aef-2631-4925-8e9e-33bae84b5912 | 2025-09-17 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Advanced Rx of Tennessee, LLC | 3b9fdc48-c071-4e2c-e063-6294a90a679f | 2025-08-05 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Asclemed USA, Inc. | d7ed42c4-371c-4a54-ab15-0630656f0427 | 2025-08-02 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NCS HealthCare of KY, LLC dba Vangard Labs | ab11e142-9e11-4ce4-9671-7e4fe53ffe92 | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 0615-8309 0615-8310 |
| Ibuprofen | IBUPROFEN | NCS HealthCare of KY, LLC dba Vangard Labs | f1842893-7a34-4f77-8231-55fb0c98b22b | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 0615-8311 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 3732defa-67c2-4b84-8a84-4bbc27b6cb24 | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 689dbbe8-4f85-48fe-8efc-fda81b60d37f | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 09621787-9a5c-4abf-9ccd-d6f8d581738f | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 42b92fd7-468c-4fb8-9ff0-31296735df4c | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 7942cc53-1268-4e5f-8db0-f0b3524bb744 | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8309 | Ibuprofen | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8309 | Ibuprofen | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8309 | Ibuprofen | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8310 | IBUPROFEN | IBUPROFEN | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8310 | Ibuprofen | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8311 | Ibuprofen | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8311 | Ibuprofen | Ibuprofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10544-084 | ibuprofen | ibuprofen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 42291-428 | Ibuprofen | Ibuprofen | AvKARE, Inc | ANDA | Current |
| 42291-428 | Ibuprofen | Ibuprofen | AvKARE | ANDA | Current |
| 42291-440 | Ibuprofen | Ibuprofen | AvKARE | ANDA | Current |
| 42291-440 | Ibuprofen | Ibuprofen | AvKARE | ANDA | Current |
| 42291-440 | Ibuprofen | Ibuprofen | AvKARE | ANDA | Current |
| 42291-441 | Ibuprofen | Ibuprofen | AvKARE | ANDA | Current |
| 42291-441 | Ibuprofen | Ibuprofen | AvKARE | ANDA | Current |
| 42291-441 | Ibuprofen | Ibuprofen | AvKARE | ANDA | Current |
| 42291-442 | Ibuprofen | Ibuprofen | AvKARE | ANDA | Current |
| 42291-442 | Ibuprofen | Ibuprofen | AvKARE | ANDA | Current |
| 42291-442 | Ibuprofen | Ibuprofen | AvKARE | ANDA | Current |
| 42291-442 | Ibuprofen | Ibuprofen | AvKARE | ANDA | Current |
| 42543-964 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-964 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-964 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-964 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-964 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-965 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-965 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-965 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-965 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-965 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-966 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-966 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-966 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-966 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 42543-966 | Ibuprofen | Ibuprofen | Strides Pharma Inc. | ANDA | Current |
| 50090-5818 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5819 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 57910-100 | Ibuprofen | Ibuprofen | Shasun Pharmaceuticals Limited | ANDA | Current |
| 57910-200 | Ibuprofen | Ibuprofen | Shasun Pharmaceuticals Limited | ANDA | Current |
| 57910-300 | Ibuprofen | Ibuprofen | Shasun Pharmaceuticals Limited | ANDA | Current |
| 60760-596 | Ibuprofen | Ibuprofen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-596 | Ibuprofen | Ibuprofen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-596 | Ibuprofen | Ibuprofen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-597 | Ibuprofen | Ibuprofen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-597 | Ibuprofen | Ibuprofen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-597 | Ibuprofen | Ibuprofen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-597 | Ibuprofen | Ibuprofen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 64380-807 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-807 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-807 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-807 | Ibuprofen | Ibuprofen | Strides Shasun Limited | ANDA | Current |
| 64380-807 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-807 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-807 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-807 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-807 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-808 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-808 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-808 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-808 | Ibuprofen | Ibuprofen | Strides Shasun Limited | ANDA | Current |
| 64380-808 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-808 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-808 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-808 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-808 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-809 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-809 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-809 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-809 | Ibuprofen | Ibuprofen | Strides Shasun Limited | ANDA | Current |
| 64380-809 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-809 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-809 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-809 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 64380-809 | Ibuprofen | Ibuprofen | Strides Pharma Science Limited | ANDA | Current |
| 67296-1686 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1686 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1706 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1706 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1716 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1716 | Ibuprofen | Ibuprofen | RedPharm Drug, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23903 | ORIG | 2009-03-03 |