Application 214367
- Type
- ANDA
- Sponsor
- MSN LABORATORIES PRIVATE LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SELEXIPAG | SELEXIPAG | UNKNOWN | UNKNOWN | No | No |
| 002 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 0.4MG | No | No |
| 003 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 0.6MG | No | No |
| 004 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 0.8MG | No | No |
| 005 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 1MG | No | No |
| 006 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 1.2MG | No | No |
| 007 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 1.4MG | No | No |
| 008 | SELEXIPAG | SELEXIPAG | TABLET;ORAL | 1.6MG | No | No |
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 |
|---|---|---|---|---|---|---|
| UPTRAVI | SELEXIPAG | Actelion Pharmaceuticals US, Inc. | a7a23b87-f892-4e2c-8e2e-ebf841220f90 | 2026-05-28 | Warnings, Adverse reactions | SELEXIPAG |
| Selexipag | SELEXIPAG | Zydus Lifesciences Limited | ff660787-880f-4f2b-baac-fd2dbfcd79c2 | 2025-11-07 | Warnings, Adverse reactions | Selexipag SELEXIPAG |
| Selexipag | SELEXIPAG | Zydus Pharmaceuticals (USA) Inc. | c604e181-e336-4194-bf96-f65dd164d461 | 2024-05-25 | Warnings, Adverse reactions | Selexipag SELEXIPAG |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67435 | ORIG | 2021-05-07 |