Application 202546
- Type
- ANDA
- Sponsor
- BEXIMCO PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RIBAVIRIN | RIBAVIRIN | TABLET;ORAL | 200MG | No | No |
| 002 | RIBAVIRIN | RIBAVIRIN | TABLET;ORAL | 400MG | No | No |
| 003 | RIBAVIRIN | RIBAVIRIN | TABLET;ORAL | 500MG | No | No |
| 004 | RIBAVIRIN | RIBAVIRIN | TABLET;ORAL | 600MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202546-001 | RIBAVIRIN | RIBAVIRIN | 200MG | TABLET / ORAL | 2014-08-12 | ||
| A202546-002 | RIBAVIRIN | RIBAVIRIN | 400MG | TABLET / ORAL | 2014-08-12 | ||
| A202546-003 | RIBAVIRIN | RIBAVIRIN | 500MG | TABLET / ORAL | 2014-08-12 | ||
| A202546-004 | RIBAVIRIN | RIBAVIRIN | 600MG | TABLET / ORAL | 2014-08-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202546-001 | RIBAVIRIN | 200MG | TABLET / ORAL | 2014-08-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202546-002 | RIBAVIRIN | 400MG | TABLET / ORAL | 2014-08-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202546-003 | RIBAVIRIN | 500MG | TABLET / ORAL | 2014-08-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202546-004 | RIBAVIRIN | 600MG | TABLET / ORAL | 2014-08-12 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202546-001 | RIBAVIRIN | 200MG | TABLET / ORAL | 2014-08-12 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202546-002 | RIBAVIRIN | 400MG | TABLET / ORAL | 2014-08-12 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202546-003 | RIBAVIRIN | 500MG | TABLET / ORAL | 2014-08-12 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202546-004 | RIBAVIRIN | 600MG | TABLET / ORAL | 2014-08-12 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202546-001 | RIBAVIRIN | 200MG | TABLET / ORAL | 2014-08-12 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202546-002 | RIBAVIRIN | 400MG | TABLET / ORAL | 2014-08-12 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202546-003 | RIBAVIRIN | 500MG | TABLET / ORAL | 2014-08-12 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202546-004 | RIBAVIRIN | 600MG | TABLET / ORAL | 2014-08-12 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202546-001 | RIBAVIRIN | 200MG | TABLET / ORAL | 2014-08-12 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202546-002 | RIBAVIRIN | 400MG | TABLET / ORAL | 2014-08-12 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202546-003 | RIBAVIRIN | 500MG | TABLET / ORAL | 2014-08-12 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202546-004 | RIBAVIRIN | 600MG | TABLET / ORAL | 2014-08-12 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202546-001 | RIBAVIRIN | 200MG | TABLET / ORAL | 2014-08-12 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202546-002 | RIBAVIRIN | 400MG | TABLET / ORAL | 2014-08-12 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202546-003 | RIBAVIRIN | 500MG | TABLET / ORAL | 2014-08-12 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202546-004 | RIBAVIRIN | 600MG | TABLET / ORAL | 2014-08-12 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202546-001 | RIBAVIRIN | 200MG | TABLET / ORAL | 2014-08-12 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202546-002 | RIBAVIRIN | 400MG | TABLET / ORAL | 2014-08-12 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202546-003 | RIBAVIRIN | 500MG | TABLET / ORAL | 2014-08-12 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202546-004 | RIBAVIRIN | 600MG | TABLET / ORAL | 2014-08-12 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202546-001 | RIBAVIRIN | 200MG | TABLET / ORAL | 2014-08-12 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202546-002 | RIBAVIRIN | 400MG | TABLET / ORAL | 2014-08-12 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202546-003 | RIBAVIRIN | 500MG | TABLET / ORAL | 2014-08-12 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202546-004 | RIBAVIRIN | 600MG | TABLET / ORAL | 2014-08-12 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202546-001 | RIBAVIRIN | 200MG | TABLET / ORAL | 2014-08-12 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202546-002 | RIBAVIRIN | 400MG | TABLET / ORAL | 2014-08-12 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202546-003 | RIBAVIRIN | 500MG | TABLET / ORAL | 2014-08-12 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202546-004 | RIBAVIRIN | 600MG | TABLET / ORAL | 2014-08-12 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202546-001 | RIBAVIRIN | 200MG | TABLET / ORAL | 2014-08-12 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202546-002 | RIBAVIRIN | 400MG | TABLET / ORAL | 2014-08-12 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202546-003 | RIBAVIRIN | 500MG | TABLET / ORAL | 2014-08-12 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202546-004 | RIBAVIRIN | 600MG | TABLET / ORAL | 2014-08-12 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202546-001 | RIBAVIRIN | 200MG | TABLET / ORAL | 2014-08-12 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202546-002 | RIBAVIRIN | 400MG | TABLET / ORAL | 2014-08-12 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202546-003 | RIBAVIRIN | 500MG | TABLET / ORAL | 2014-08-12 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202546-004 | RIBAVIRIN | 600MG | TABLET / ORAL | 2014-08-12 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A202546-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202546-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202546-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202546-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A202546-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A202546-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A202546-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A202546-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A202546-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A202546-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A202546-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A202546-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A202546-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A202546-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A202546-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A202546-004 | 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 |
|---|---|---|---|---|---|---|
| Ribavirin | RIBAVIRIN | Aurobindo Pharma Limited | 35f99f76-f2ef-4a81-91ff-285419664be3 | 2024-02-06 | Boxed warning, Warnings, Adverse reactions | Ribavirin RIBAVIRIN |
| Ribavirin | RIBAVIRIN | Aurobindo Pharma Limited | eee304d0-c2ea-44f4-97d9-92a414d31b6c | 2024-02-06 | Boxed warning, Warnings, Adverse reactions | Ribavirin RIBAVIRIN |
| Ribavirin | RIBAVIRIN | Oceanside Pharmaceuticals | d74aa4f3-0b7d-480d-b5bf-41ddf808b260 | 2019-05-01 | Boxed warning, Warnings, Adverse reactions | Ribavirin RIBAVIRIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.