Application 208272
- Type
- ANDA
- Sponsor
- TORRENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROFLUMILAST | ROFLUMILAST | TABLET;ORAL | 500MCG | No | No |
| 002 | ROFLUMILAST | ROFLUMILAST | TABLET;ORAL | 250MCG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208272-001 | ROFLUMILAST | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | ||
| A208272-002 | ROFLUMILAST | ROFLUMILAST | 250MCG | TABLET / ORAL | 2024-10-18 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208272-002 | ROFLUMILAST | 250MCG | TABLET / ORAL | 2024-10-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208272-002 | ROFLUMILAST | 250MCG | TABLET / ORAL | 2024-10-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208272-002 | ROFLUMILAST | 250MCG | TABLET / ORAL | 2024-10-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208272-002 | ROFLUMILAST | 250MCG | TABLET / ORAL | AB | 2024-10-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208272-002 | ROFLUMILAST | 250MCG | TABLET / ORAL | AB | 2024-10-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208272-002 | ROFLUMILAST | 250MCG | TABLET / ORAL | AB | 2024-10-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208272-002 | ROFLUMILAST | 250MCG | TABLET / ORAL | AB | 2024-10-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208272-002 | ROFLUMILAST | 250MCG | TABLET / ORAL | AB | 2024-10-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208272-002 | ROFLUMILAST | 250MCG | TABLET / ORAL | AB | 2024-10-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | AB | 2018-08-06 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | AB | 2018-08-06 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | AB | 2018-08-06 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | AB | 2018-08-06 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | AB | 2018-08-06 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | AB | 2018-08-06 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | AB | 2018-08-06 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | AB | 2018-08-06 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | AB | 2018-08-06 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | AB | 2018-08-06 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | AB | 2018-08-06 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | AB | 2018-08-06 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | AB | 2018-08-06 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A208272-001 | ROFLUMILAST | 500MCG | TABLET / ORAL | 2018-08-06 | ea1830bbd6c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A208272-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208272-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208272-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208272-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208272-002 | AB | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208272-002 | AB | 1 | d8e5a09893c0… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208272-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A208272-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A208272-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A208272-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A208272-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A208272-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208272-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A208272-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A208272-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A208272-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A208272-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A208272-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A208272-001 | AB | 1 | ea99ee380514… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208272-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208272-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208272-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A208272-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A208272-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208272-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A208272-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A208272-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208272-001 | AB | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| ZORYVE | ROFLUMILAST | Arcutis Biotherapeutics, Inc. | ec1bb0d1-f38a-4080-831a-68791d1d1fdb | 2026-07-20 | Adverse reactions | ROFLUMILAST |
| Roflumilast | ROFLUMILAST | Jubilant Cadista Pharmaceuticals Inc. | aaa81c1b-f63d-4e61-8bfa-9d42d92043c7 | 2026-07-14 | Warnings, Adverse reactions | Roflumilast ROFLUMILAST |
| roflumilast | ROFLUMILAST | AvKARE | 55009549-3f0c-1f58-e063-6294a90a6c03 | 2026-06-24 | Warnings, Adverse reactions | roflumilast ROFLUMILAST |
| ZORYVE | ROFLUMILAST | Arcutis Biotherapeutics, Inc. | f9e0b4a9-a227-4947-b00c-41fb18d16589 | 2026-06-22 | Warnings, Adverse reactions | ROFLUMILAST |
| ROFLUMILAST | ROFLUMILAST | Amici Pharma Inc. | cb3781ff-5350-4f9a-b247-0b04eb0f2b92 | 2026-05-19 | Warnings, Adverse reactions | ROFLUMILAST ROFLUMILAST |
| Roflumilast | ROFLUMILAST | Major Pharmaceuticals | ca22f3e0-6f33-4f1c-97e5-0c962891067a | 2025-12-10 | Warnings, Adverse reactions | Roflumilast ROFLUMILAST |
| Roflumilast | ROFLUMILAST | MAJOR PHARMACEUTICALS | c51b80f3-a591-4db9-81b4-b91603e35d7c | 2025-12-04 | Warnings, Adverse reactions | Roflumilast ROFLUMILAST |
| ROFLUMILAST | ROFLUMILAST | Micro Labs Limited | dc2a689f-cfa4-4863-9623-a9813dcf86a9 | 2025-07-24 | Warnings, Adverse reactions | ROFLUMILAST ROFLUMILAST |
| ROFLUMILAST | ROFLUMILAST | Aurobindo Pharma Limited | 7cb11d48-6bb9-437b-bc7f-382050a2d3e6 | 2025-05-27 | Warnings, Adverse reactions | ROFLUMILAST ROFLUMILAST |
| Roflumilast | ROFLUMILAST | Golden State Medical Supply, Inc. | 30dd6eae-6435-cae1-e063-6294a90a003b | 2025-03-21 | Warnings, Adverse reactions | Roflumilast ROFLUMILAST |
| Roflumilast | ROFLUMILAST | Ascend Laboratories, LLC | 93d72a99-64dc-4fde-a5b8-78331fa60787 | 2025-03-13 | Warnings, Adverse reactions | Roflumilast ROFLUMILAST |
| Roflumilast | ROFLUMILAST | American Health Packaging | 913f1b95-9c46-40d5-a6e9-cff2e5e07eaa | 2024-11-21 | Warnings, Adverse reactions | Roflumilast ROFLUMILAST |
| Roflumilast | ROFLUMILAST | Novadoz Pharmaceuticals LLC | 4d25f69c-58b7-4e2a-b835-4d0c76a83c7c | 2024-08-27 | Warnings, Adverse reactions | Roflumilast ROFLUMILAST |
| Roflumilast | ROFLUMILAST | Zydus Pharmaceuticals USA Inc. | 84145572-f320-4c3f-ab29-bd9f6c18746c | 2024-08-16 | Warnings, Adverse reactions | Roflumilast ROFLUMILAST |
| ROFLUMILAST | ROFLUMILAST | Bryant Ranch Prepack | fa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72 | 2024-08-15 | Warnings, Adverse reactions | ROFLUMILAST ROFLUMILAST |
| Roflumilast | ROFLUMILAST | Zydus Lifesciences Limited | e87287bd-eae3-46c3-9072-04800aeabf40 | 2024-08-12 | Roflumilast ROFLUMILAST | |
| Roflumilast | ROFLUMILAST | Camber Pharmaceuticals, Inc. | f25a0230-3cf6-4366-bebe-0ea5ff8de5ab | 2023-04-28 | Warnings, Adverse reactions | Roflumilast ROFLUMILAST |
| ROFLUMILAST | ROFLUMILAST | Solco Healthcare US, LLC. | 4251c764-7224-4f94-9de7-b6c76cb1f5cd | 2022-05-10 | Warnings, Adverse reactions | ROFLUMILAST ROFLUMILAST |
| Daliresp | ROFLUMILAST | AstraZeneca Pharmaceuticals LP | c9a1d0a8-581f-4f91-a2b8-f419192d0ebf | 2020-03-12 | Warnings, Adverse reactions | ROFLUMILAST |