Application 201503
- Type
- ANDA
- Sponsor
- APOTEX CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CABERGOLINE | CABERGOLINE | TABLET;ORAL | 0.5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201503-001 | CABERGOLINE | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 |
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 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A201503-001 | CABERGOLINE | 0.5MG | TABLET / ORAL | 2013-03-08 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Cabergoline | CABERGOLINE | Mylan Pharmaceuticals Inc. | e497366b-a124-4d7f-bd45-a883c392d4bb | 2026-06-30 | Warnings, Adverse reactions | Cabergoline CABERGOLINE |
| CABERGOLINE | CABERGOLINE | Cranbury Pharmaceuticals, LLC | 8562f94f-a59a-4893-aefc-ea6547b01e92 | 2026-06-22 | Warnings, Adverse reactions | CABERGOLINE CABERGOLINE |
| Cabergoline | CABERGOLINE | A-S Medication Solutions | c9f0b576-d5e5-4e3e-bb5c-3574d75d9907 | 2026-03-19 | Warnings, Adverse reactions | Cabergoline CABERGOLINE |
| Cabergoline | CABERGOLINE | SOLA Pharmaceuticals, LLC | 275a6a25-c3c9-4258-a610-0b00752517f7 | 2025-12-08 | Warnings, Adverse reactions | Cabergoline CABERGOLINE |
| Cabergoline | CABERGOLINE | A-S Medication Solutions | 9405c116-4a77-4e14-9ab8-25e899595cdf | 2025-08-27 | Warnings, Adverse reactions | Cabergoline CABERGOLINE |
| Cabergoline | CABERGOLINE | Ingenus Pharmaceuticals, LLC | 57cbd81e-fdb9-4060-80ee-6e8581c463a4 | 2025-07-04 | Warnings, Adverse reactions | Cabergoline CABERGOLINE |
| Cabergoline | CABERGOLINE | Teva Pharmaceuticals USA, Inc. | 74b61e8a-7ae9-4996-85ec-df23c56de16f | 2025-06-16 | Warnings, Adverse reactions | Cabergoline CABERGOLINE |
| CABERGOLINE | CABERGOLINE | Somerset Therapeutics, LLC | e0fb5556-de2c-4822-9960-0700e2907890 | 2024-11-14 | Warnings, Adverse reactions | CABERGOLINE CABERGOLINE |
| Cabergoline | CABERGOLINE | Amneal Pharmaceuticals NY LLC | a246b015-e19c-4b4f-9089-aea1108687ba | 2024-10-03 | Warnings, Adverse reactions | Cabergoline CABERGOLINE |
| Cabergoline | CABERGOLINE | A-S Medication Solutions | 7699d938-3f62-4e13-9b33-3e581310b9f3 | 2023-08-28 | Warnings, Adverse reactions | Cabergoline CABERGOLINE |
| Cabergoline | CABERGOLINE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | bc44d11b-b3f0-4e3d-9da3-4f8852d11734 | 2023-07-27 | Warnings, Adverse reactions | Cabergoline CABERGOLINE |
| Cabergoline | CABERGOLINE | A-S Medication Solutions | 89ec147b-a6fe-49bb-9af5-52fc2ce5db7f | 2023-04-12 | Warnings, Adverse reactions | Cabergoline CABERGOLINE |