Application 207011
- Type
- ANDA
- Sponsor
- UNICHEM LABS 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 |
|---|---|---|---|---|---|---|---|
| A207011-001 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | 2018-12-19 | ||
| A207011-002 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | 2018-12-19 | ||
| A207011-003 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | 2018-12-19 | ||
| A207011-004 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | 2018-12-19 | ||
| A207011-005 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | 2018-12-19 | ||
| A207011-006 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | 2018-12-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207011-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | 2018-12-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207011-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | 2018-12-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207011-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | 2018-12-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207011-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | 2018-12-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207011-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | 2018-12-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207011-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | 2018-12-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207011-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | 2018-12-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207011-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | 2018-12-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207011-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | 2018-12-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207011-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | 2018-12-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207011-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | 2018-12-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207011-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | 2018-12-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207011-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | 2018-12-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207011-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | 2018-12-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207011-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | 2018-12-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207011-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | 2018-12-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207011-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | 2018-12-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207011-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | 2018-12-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207011-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | 2018-12-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207011-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | 2018-12-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207011-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | 2018-12-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207011-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | 2018-12-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207011-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | 2018-12-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207011-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | 2018-12-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207011-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | 2018-12-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207011-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | 2018-12-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207011-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | 2018-12-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207011-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | 2018-12-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207011-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | 2018-12-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207011-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | 2018-12-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207011-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | 2018-12-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207011-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | 2018-12-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207011-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | 2018-12-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207011-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | 2018-12-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207011-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | 2018-12-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207011-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | 2018-12-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207011-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | 2018-12-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207011-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | 2018-12-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207011-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | 2018-12-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207011-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | 2018-12-19 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A207011-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207011-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207011-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207011-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207011-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207011-006 | AB | 1 | 74a2ff9319b5… |
| 2020-11-12 02:37 UTC | 2020-11 | A207011-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A207011-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A207011-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A207011-004 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A207011-005 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A207011-006 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A207011-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A207011-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A207011-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A207011-004 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A207011-005 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A207011-006 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A207011-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A207011-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A207011-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A207011-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A207011-005 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A207011-006 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A207011-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207011-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207011-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207011-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207011-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207011-006 | AB | 1 | ea99ee380514… |
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 | 207011 ANDA207011 29300-208 29300-210 29300-207 29300-270 29300-211 29300-209 |
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 |
|---|---|---|---|---|---|
| 29300-207 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-207 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-207 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-207 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-207 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-207 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-208 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-208 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-208 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-208 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-208 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-208 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-209 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-209 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-209 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-209 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-209 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-209 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-210 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-210 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-210 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-210 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-210 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-210 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-211 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-211 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-211 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-211 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-211 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-211 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-270 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-270 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-270 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-270 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-270 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-270 | pramipexole dihydrochloride | pramipexole dihydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |