Application 022514
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 0.375MG | No | No |
| 002 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 0.75MG | No | No |
| 003 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 1.5MG | No | No |
| 004 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 3MG | No | No |
| 005 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 4.5MG | No | No |
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 |
|---|---|---|---|---|---|---|
| pramipexole dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | b978aa75-c62d-444b-9ec6-6c0d21a66688 | 2025-10-14 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Aurobindo Pharma Limited | 3f90971a-e005-4dd3-bb93-b09125ada3c8 | 2025-10-03 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| pramipexole dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Strides Pharma Science Limited | fb2260d6-204c-4d25-a331-0f8340d83a6e | 2025-08-17 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Ingenus Pharmaceuticals, LLC | 1d2b1d2c-ae22-424a-bad7-ce24a817b042 | 2025-04-24 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 5e6f2187-a5cc-481e-b0a1-d38d3f92e822 | 2024-10-09 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | 350a3f84-0f98-405f-bdae-6abbc47d48a4 | 2024-08-29 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | NorthStar RxLLC | 946c8a72-8c48-4925-93d3-7940f4c0fd29 | 2024-08-20 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole Dihydrochloride Extended-Release | PRAMIPEXOLE DIHYDROCHLORIDE | Vitruvias Therapeutics, Inc. | d07aad1b-e078-4fca-8386-ca2e8e899688 | 2024-07-23 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Macleods Pharmaceuticals Limited | 1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be | 2024-07-06 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Alembic Pharmaceuticals Inc. | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 2024-06-20 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | A-S Medication Solutions | 7cd6a546-d516-427c-af79-555390ccd35b | 2023-12-15 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Alembic Pharmaceuticals Limited | 0a3ed933-ef5b-4091-8ae9-5768ae18514f | 2023-12-08 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Alembic Pharmaceuticals Limited | b6935240-ee81-49ef-adad-fb900d7f5127 | 2023-01-27 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Dr. Reddy's Laboratories Limited | 00699692-532a-68fd-8a51-3770a81b2208 | 2021-08-31 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole Dihydrochloride Extended-Release | PRAMIPEXOLE DIHYDROCHLORIDE | Xiamen LP Pharmaceutical Co., Ltd. | 1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c | 2021-06-16 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Alembic Pharmaceuticals Limited | 92f6ef1e-3256-45a7-a409-80dd85e95187 | 2017-11-20 | Warnings, Adverse reactions | PRAMIPEXOLE DIHYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.