Application 214302
- Type
- ANDA
- Sponsor
- ZYDUS WORLDWIDE DMCC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 0.2MG | No | No |
| 002 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 400MCG | No | No |
| 003 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 600MCG | No | No |
| 004 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 800MCG | No | No |
| 005 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 1000MC | No | No |
| 006 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 1200MCG | No | No |
| 007 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 1400MCG | No | No |
| 008 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 1600MCG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214302-001 | SELEXIPAG | SELEXIPAG | 0.2MG | TABLET / ORAL | 2022-12-21 | ||
| A214302-002 | SELEXIPAG | SELEXIPAG | 0.4MG | TABLET / ORAL | 2022-12-21 | ||
| A214302-003 | SELEXIPAG | SELEXIPAG | 0.6MG | TABLET / ORAL | 2022-12-21 | ||
| A214302-004 | SELEXIPAG | SELEXIPAG | 0.8MG | TABLET / ORAL | 2022-12-21 | ||
| A214302-005 | SELEXIPAG | SELEXIPAG | 1MG | TABLET / ORAL | 2022-12-21 | ||
| A214302-006 | SELEXIPAG | SELEXIPAG | 1.2MG | TABLET / ORAL | 2022-12-21 | ||
| A214302-007 | SELEXIPAG | SELEXIPAG | 1.4MG | TABLET / ORAL | 2022-12-21 | ||
| A214302-008 | SELEXIPAG | SELEXIPAG | 1.6MG | TABLET / ORAL | 2022-12-21 |
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 | A214302-001 | SELEXIPAG | 0.2MG | TABLET / ORAL | 2022-12-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214302-002 | SELEXIPAG | 0.4MG | TABLET / ORAL | 2022-12-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214302-003 | SELEXIPAG | 0.6MG | TABLET / ORAL | 2022-12-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214302-004 | SELEXIPAG | 0.8MG | TABLET / ORAL | 2022-12-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214302-005 | SELEXIPAG | 1MG | TABLET / ORAL | 2022-12-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214302-006 | SELEXIPAG | 1.2MG | TABLET / ORAL | 2022-12-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214302-007 | SELEXIPAG | 1.4MG | TABLET / ORAL | 2022-12-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214302-008 | SELEXIPAG | 1.6MG | TABLET / ORAL | 2022-12-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214302-001 | SELEXIPAG | 0.2MG | TABLET / ORAL | 2022-12-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214302-002 | SELEXIPAG | 0.4MG | TABLET / ORAL | 2022-12-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214302-003 | SELEXIPAG | 0.6MG | TABLET / ORAL | 2022-12-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214302-004 | SELEXIPAG | 0.8MG | TABLET / ORAL | 2022-12-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214302-005 | SELEXIPAG | 1MG | TABLET / ORAL | 2022-12-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214302-006 | SELEXIPAG | 1.2MG | TABLET / ORAL | 2022-12-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214302-007 | SELEXIPAG | 1.4MG | TABLET / ORAL | 2022-12-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214302-008 | SELEXIPAG | 1.6MG | TABLET / ORAL | 2022-12-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214302-001 | SELEXIPAG | 0.2MG | TABLET / ORAL | 2022-12-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214302-002 | SELEXIPAG | 0.4MG | TABLET / ORAL | 2022-12-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214302-003 | SELEXIPAG | 0.6MG | TABLET / ORAL | 2022-12-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214302-004 | SELEXIPAG | 0.8MG | TABLET / ORAL | 2022-12-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214302-005 | SELEXIPAG | 1MG | TABLET / ORAL | 2022-12-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214302-006 | SELEXIPAG | 1.2MG | TABLET / ORAL | 2022-12-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214302-007 | SELEXIPAG | 1.4MG | TABLET / ORAL | 2022-12-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214302-008 | SELEXIPAG | 1.6MG | TABLET / ORAL | 2022-12-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214302-001 | SELEXIPAG | 0.2MG | TABLET / ORAL | 2022-12-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214302-002 | SELEXIPAG | 0.4MG | TABLET / ORAL | 2022-12-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214302-003 | SELEXIPAG | 0.6MG | TABLET / ORAL | 2022-12-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214302-004 | SELEXIPAG | 0.8MG | TABLET / ORAL | 2022-12-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214302-005 | SELEXIPAG | 1MG | TABLET / ORAL | 2022-12-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214302-006 | SELEXIPAG | 1.2MG | TABLET / ORAL | 2022-12-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214302-007 | SELEXIPAG | 1.4MG | TABLET / ORAL | 2022-12-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214302-008 | SELEXIPAG | 1.6MG | TABLET / ORAL | 2022-12-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214302-001 | SELEXIPAG | 0.2MG | TABLET / ORAL | 2022-12-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214302-002 | SELEXIPAG | 0.4MG | TABLET / ORAL | 2022-12-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214302-003 | SELEXIPAG | 0.6MG | TABLET / ORAL | 2022-12-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214302-004 | SELEXIPAG | 0.8MG | TABLET / ORAL | 2022-12-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214302-005 | SELEXIPAG | 1MG | TABLET / ORAL | 2022-12-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214302-006 | SELEXIPAG | 1.2MG | TABLET / ORAL | 2022-12-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214302-007 | SELEXIPAG | 1.4MG | TABLET / ORAL | 2022-12-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214302-008 | SELEXIPAG | 1.6MG | TABLET / ORAL | 2022-12-21 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-05-13 08:27 UTC | 2023-05 | A214302-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A214302-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A214302-003 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A214302-004 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A214302-005 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A214302-006 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A214302-007 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A214302-008 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A214302-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A214302-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A214302-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A214302-004 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A214302-005 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A214302-006 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A214302-007 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A214302-008 | AB | 1 | 3bdfa0b2c4d7… |
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 |
|---|---|---|---|---|---|---|
| Selexipag | SELEXIPAG | Zydus Lifesciences Limited | ff660787-880f-4f2b-baac-fd2dbfcd79c2 | 2025-11-07 | Warnings, Adverse reactions | 214302 ANDA214302 |
| Selexipag | SELEXIPAG | Zydus Pharmaceuticals (USA) Inc. | c604e181-e336-4194-bf96-f65dd164d461 | 2024-05-25 | Warnings, Adverse reactions | 214302 ANDA214302 |