Application 202633
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET;ORAL | 0.125MG | No | No |
| 002 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET;ORAL | 0.25MG | No | No |
| 003 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET;ORAL | 0.5MG | No | No |
| 004 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET;ORAL | 0.75MG | No | No |
| 005 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET;ORAL | 1MG | No | No |
| 006 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET;ORAL | 1.5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202633-001 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2012-10-26 | |
| A202633-002 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2012-10-26 | |
| A202633-003 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2012-10-26 | |
| A202633-004 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2012-10-26 | |
| A202633-005 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2012-10-26 | |
| A202633-006 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2012-10-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202633-001 | AB |
| A202633-002 | AB |
| A202633-003 | AB |
| A202633-004 | AB |
| A202633-005 | AB |
| A202633-006 | 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 | A202633-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2012-10-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202633-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2012-10-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202633-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2012-10-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202633-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2012-10-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202633-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2012-10-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202633-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2012-10-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202633-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2012-10-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202633-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2012-10-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202633-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2012-10-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202633-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2012-10-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202633-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2012-10-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202633-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2012-10-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202633-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2012-10-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202633-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2012-10-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202633-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2012-10-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202633-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2012-10-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202633-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2012-10-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202633-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2012-10-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202633-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2012-10-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202633-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2012-10-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202633-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2012-10-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202633-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2012-10-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202633-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2012-10-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202633-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2012-10-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202633-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2012-10-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202633-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2012-10-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202633-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2012-10-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202633-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2012-10-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202633-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2012-10-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202633-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2012-10-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202633-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2012-10-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202633-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2012-10-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202633-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2012-10-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202633-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2012-10-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202633-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2012-10-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202633-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2012-10-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202633-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2012-10-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202633-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2012-10-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202633-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2012-10-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202633-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2012-10-26 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202633-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202633-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202633-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202633-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202633-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202633-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202633-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202633-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202633-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202633-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202633-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202633-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202633-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202633-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202633-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202633-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202633-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202633-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202633-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202633-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202633-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202633-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202633-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202633-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202633-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202633-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202633-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202633-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202633-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202633-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202633-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202633-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202633-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202633-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202633-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202633-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202633-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202633-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202633-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202633-004 | AB | 1 | 2680178bc6a6… |
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 | Bryant Ranch Prepack | 468830df-941c-4363-b432-94de9b7fd2ac | 2026-06-29 | Warnings, Adverse reactions | 202633 ANDA202633 71335-1537 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | 7a5d1b22-179a-44ae-9545-2704414b9905 | 2026-05-15 | Warnings, Adverse reactions | 202633 ANDA202633 71335-1877 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | f1ff3695-33db-471d-a3db-89fbb9ed9e0c | 2026-05-14 | Warnings, Adverse reactions | 202633 ANDA202633 71335-1808 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | 422b27af-5e7d-4fe1-81bc-ed545c26b476 | 2026-04-17 | Warnings, Adverse reactions | 202633 ANDA202633 71335-1504 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | 1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad | 2026-04-07 | Warnings, Adverse reactions | 202633 ANDA202633 63629-8289 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Rising Pharma Holdings, Inc. | 56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec | 2025-12-11 | Warnings, Adverse reactions | 202633 ANDA202633 57237-184 57237-185 57237-183 57237-182 57237-180 57237-181 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Aurobindo Pharma Limited | 3f90971a-e005-4dd3-bb93-b09125ada3c8 | 2025-10-03 | Warnings, Adverse reactions | 202633 ANDA202633 65862-605 65862-608 65862-609 65862-604 65862-607 65862-606 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | A-S Medication Solutions | 29b639e3-25a5-4c2f-b4ea-a119db79fe0c | 2024-03-17 | Warnings, Adverse reactions | 202633 ANDA202633 50090-2455 50090-3280 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | A-S Medication Solutions | 7cd6a546-d516-427c-af79-555390ccd35b | 2023-12-15 | Warnings, Adverse reactions | 202633 ANDA202633 50090-5036 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-2455 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2455 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2455 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2455 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3280 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3280 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3280 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3280 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3280 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3280 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3280 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5036 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5036 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5036 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | A-S Medication Solutions | ANDA | Current |
| 57237-180 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-180 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-180 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-180 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-181 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-181 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-181 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-181 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-182 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-182 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-182 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-182 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-183 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-183 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-183 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-183 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-184 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-184 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-184 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-184 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-185 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-185 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-185 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-185 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Rising Health, LLC | ANDA | Current |
| 63629-8289 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8289 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 65862-604 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-604 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-604 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-604 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-604 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-605 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-605 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-605 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-605 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-605 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-606 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-606 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-606 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-606 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-606 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-607 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-607 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-607 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-607 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-607 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-608 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-608 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-608 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-608 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-608 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-609 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-609 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-609 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-609 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-609 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 71335-1504 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1504 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1537 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1537 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1808 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1808 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1877 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1877 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |