Application 090865
- Type
- ANDA
- Sponsor
- TORRENT PHARMS
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 |
|---|---|---|---|---|---|---|---|
| A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | |
| A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | |
| A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | |
| A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | |
| A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | |
| A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090865-001 | AB |
| A090865-002 | AB |
| A090865-003 | AB |
| A090865-004 | AB |
| A090865-005 | AB |
| A090865-006 | 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 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | 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 | A090865-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-004 | 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 | 46f88017-7b0e-437e-90b1-37bdf9013e72 | 2026-05-22 | Warnings, Adverse reactions | 090865 ANDA090865 71335-2167 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | A-S Medication Solutions | 3db0613d-524b-4b33-9a07-602f84d6c304 | 2026-04-26 | Warnings, Adverse reactions | 090865 ANDA090865 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | bd0f7ae1-11ef-4fab-894f-c4c59f75aa99 | 2026-04-03 | Warnings, Adverse reactions | 090865 ANDA090865 63629-5042 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | dd4b4e2a-97b5-417d-bb90-bec692dc359b | 2026-04-02 | Warnings, Adverse reactions | 090865 ANDA090865 63629-5013 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Torrent Pharmaceuticals Limited | 60167d7c-469f-455a-a113-561841af5e59 | 2026-03-31 | Warnings, Adverse reactions | 090865 ANDA090865 13668-091 13668-094 13668-093 13668-184 13668-092 13668-095 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | American Health Packaging | f4d97c2e-f447-4cfe-b9d4-852323f0cfb5 | 2026-03-03 | Warnings, Adverse reactions | 090865 ANDA090865 60687-570 60687-581 60687-592 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Major Pharmaceuticals | 978c0e89-35f0-44a2-9302-8bed7e5d60e0 | 2026-01-21 | Warnings, Adverse reactions | 090865 ANDA090865 0904-6704 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | 794fdab8-1c15-4469-963e-4f9e3495536f | 2025-11-17 | Warnings, Adverse reactions | 090865 ANDA090865 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | 350a3f84-0f98-405f-bdae-6abbc47d48a4 | 2024-08-29 | Warnings, Adverse reactions | 090865 ANDA090865 71335-0584 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6704 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6704 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6704 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Major Pharmaceuticals | ANDA | Current |
| 13668-091 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-091 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-091 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-091 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-091 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-091 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-091 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-092 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-092 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-092 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-092 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-092 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-092 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-092 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-093 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-093 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-093 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-093 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-093 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-093 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-093 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-094 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-094 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-094 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-094 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-094 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-094 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-094 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-095 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-095 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-095 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-095 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-095 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-095 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-095 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-184 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-184 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-184 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-184 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-184 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-184 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-184 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 60687-570 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | American Health Packaging | ANDA | Current |
| 60687-570 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | American Health Packaging | ANDA | Current |
| 60687-581 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | American Health Packaging | ANDA | Current |
| 60687-581 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | American Health Packaging | ANDA | Current |
| 60687-592 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | American Health Packaging | ANDA | Current |
| 60687-592 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | American Health Packaging | ANDA | Current |
| 63629-5013 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-5013 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-5013 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-5013 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-5042 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-5042 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-5042 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-5042 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7384 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7384 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 68151-0329 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Carilion Materials Management | ANDA | Current |
| 68151-3645 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Carilion Materials Management | ANDA | Current |
| 68151-3966 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Carilion Materials Management | ANDA | Current |
| 71335-0584 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0584 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0584 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0584 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-2167 | Pramipexole Dihydrochloride | Pramipexole Dihydrochloride | Bryant Ranch Prepack | ANDA | Current |