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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | caaa826d4ba7… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078329-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078329-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078329-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078329-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078329-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078329-003 | AB | 1 | caaa826d4ba7… |
| 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… |
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 | Aphena Pharma Solutions - Tennessee, LLC | 31f59d10-d821-2291-e063-6294a90ac518 | 2025-04-04 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 3140a614-c7ae-3062-e063-6394a90ad3d7 | 2025-03-26 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | SOLA Pharmaceuticals, LLC | b19b8c34-e0c1-4982-92fc-34dbe7384935 | 2024-12-02 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 1361b6d6-0443-460a-8446-41f63a1e28df | 2024-10-28 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 92efad86-31ae-78e5-e053-2995a90a0fda | 2024-07-03 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | a2160213-2a32-2044-e053-2995a90a21af | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 8c3dccbb-1084-cd09-e053-2a95a90ac12a | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 8cb93e5f-4ebc-24b7-e053-2a95a90a5a23 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 88795f0e-41b7-504e-e053-2995a90a3b9e | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Amneal Pharmaceuticals NY LLC | e07d989d-1b0e-4cc1-abf2-93c8b208a29a | 2023-12-30 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 7152b6ce-6113-4003-bf80-aa263be69392 | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 50090-5818 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 400faee1-f662-470e-bcd6-7711dfaf9ba2 | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 50090-5819 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 91723661-d0bb-4498-ac59-59bbdc334230 | 2022-01-27 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | 8813a8a4-ebbd-4204-88a3-600a92ea9170 | 2020-12-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
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 |
|---|---|---|---|---|---|
| 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 |