Application 210342
- Type
- ANDA
- Sponsor
- CIPLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BOSENTAN | BOSENTAN | TABLET;ORAL | 62.5MG | No | No |
| 002 | BOSENTAN | BOSENTAN | TABLET;ORAL | 125MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210342-001 | BOSENTAN | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | ||
| A210342-002 | BOSENTAN | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2021-12-28 21:50 UTC | 2021-12 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210342-001 | BOSENTAN | 62.5MG | TABLET / ORAL | 2020-01-03 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210342-002 | BOSENTAN | 125MG | TABLET / ORAL | 2020-01-03 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Bosentan | BOSENTAN | Zydus Pharmaceuticals USA Inc. | 8444da17-6c31-492b-8842-93740f083d9d | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | Bosentan BOSENTAN |
| bosentan | BOSENTAN | Zydus Lifesciences Limited | b88cc559-93ae-42db-9c38-fb5e9c4802e6 | 2026-02-14 | bosentan BOSENTAN | |
| Bosentan | BOSENTAN | Sun Pharmaceutical Industries, Inc. | c006d8ef-8cb7-4fb3-88eb-b2debc302a20 | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | Bosentan BOSENTAN |
| Tracleer | BOSENTAN | Actelion Pharmaceuticals US, Inc. | 749e42fb-2fe0-45dd-9268-b43bb3f4081c | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | BOSENTAN |
| bosentan | BOSENTAN | Zydus Pharmaceuticals USA Inc. | c1e75179-cbea-4535-8709-f6d79c1d4004 | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | bosentan BOSENTAN |
| Bosentan | BOSENTAN | Lupin Pharmaceuticals, Inc. | 540b6f6a-79f3-4681-8c2a-268cf7cecbc9 | 2025-11-03 | Boxed warning, Warnings, Adverse reactions | Bosentan BOSENTAN |
| bosentan | BOSENTAN | Actavis Pharma, Inc. | 39b2a85f-4322-42d4-b420-1b1d52569143 | 2025-11-01 | Boxed warning, Warnings, Adverse reactions | bosentan BOSENTAN |
| Bosentan | BOSENTAN | Zydus Lifesciences Limited | 02892f47-0d59-4254-9ee7-d524278fdd79 | 2024-11-25 | Bosentan BOSENTAN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.