Home Applications 214414 Application 214414
Type ANDA
Sponsor ALEMBIC PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SELEXIPAG SELEXIPAG TABLET;ORAL 0.2MG 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 1.4MG No No 006 SELEXIPAG SELEXIPAG TABLET;ORAL 1.6MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214414-001 SELEXIPAG SELEXIPAG 0.2MG TABLET / ORAL AB 2023-10-11 A214414-002 SELEXIPAG SELEXIPAG 0.4MG TABLET / ORAL AB 2023-10-11 A214414-003 SELEXIPAG SELEXIPAG 0.6MG TABLET / ORAL AB 2023-10-11 A214414-004 SELEXIPAG SELEXIPAG 0.8MG TABLET / ORAL AB 2023-10-11 A214414-005 SELEXIPAG SELEXIPAG 1.4MG TABLET / ORAL AB 2023-10-11 A214414-006 SELEXIPAG SELEXIPAG 1.6MG TABLET / ORAL AB 2023-10-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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.
Product history page 2 of 4 · 138 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214414-005 SELEXIPAG 1.4MG TABLET / ORAL AB 2023-10-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214414-006 SELEXIPAG 1.6MG TABLET / ORAL AB 2023-10-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214414-001 SELEXIPAG 0.2MG TABLET / ORAL AB 2023-10-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214414-002 SELEXIPAG 0.4MG TABLET / ORAL AB 2023-10-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214414-003 SELEXIPAG 0.6MG TABLET / ORAL AB 2023-10-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214414-004 SELEXIPAG 0.8MG TABLET / ORAL AB 2023-10-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214414-005 SELEXIPAG 1.4MG TABLET / ORAL AB 2023-10-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214414-006 SELEXIPAG 1.6MG TABLET / ORAL AB 2023-10-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214414-001 SELEXIPAG 0.2MG TABLET / ORAL AB 2023-10-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214414-002 SELEXIPAG 0.4MG TABLET / ORAL AB 2023-10-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214414-003 SELEXIPAG 0.6MG TABLET / ORAL AB 2023-10-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214414-004 SELEXIPAG 0.8MG TABLET / ORAL AB 2023-10-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214414-005 SELEXIPAG 1.4MG TABLET / ORAL AB 2023-10-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214414-006 SELEXIPAG 1.6MG TABLET / ORAL AB 2023-10-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214414-001 SELEXIPAG 0.2MG TABLET / ORAL AB 2023-10-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214414-002 SELEXIPAG 0.4MG TABLET / ORAL AB 2023-10-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214414-003 SELEXIPAG 0.6MG TABLET / ORAL AB 2023-10-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214414-004 SELEXIPAG 0.8MG TABLET / ORAL AB 2023-10-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214414-005 SELEXIPAG 1.4MG TABLET / ORAL AB 2023-10-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214414-006 SELEXIPAG 1.6MG TABLET / ORAL AB 2023-10-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214414-001 SELEXIPAG 0.2MG TABLET / ORAL AB 2023-10-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214414-002 SELEXIPAG 0.4MG TABLET / ORAL AB 2023-10-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214414-003 SELEXIPAG 0.6MG TABLET / ORAL AB 2023-10-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214414-004 SELEXIPAG 0.8MG TABLET / ORAL AB 2023-10-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214414-005 SELEXIPAG 1.4MG TABLET / ORAL AB 2023-10-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214414-006 SELEXIPAG 1.6MG TABLET / ORAL AB 2023-10-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214414-001 SELEXIPAG 0.2MG TABLET / ORAL AB 2023-10-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214414-002 SELEXIPAG 0.4MG TABLET / ORAL AB 2023-10-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214414-003 SELEXIPAG 0.6MG TABLET / ORAL AB 2023-10-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214414-004 SELEXIPAG 0.8MG TABLET / ORAL AB 2023-10-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214414-005 SELEXIPAG 1.4MG TABLET / ORAL AB 2023-10-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214414-006 SELEXIPAG 1.6MG TABLET / ORAL AB 2023-10-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214414-001 SELEXIPAG 0.2MG TABLET / ORAL AB 2023-10-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214414-002 SELEXIPAG 0.4MG TABLET / ORAL AB 2023-10-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214414-003 SELEXIPAG 0.6MG TABLET / ORAL AB 2023-10-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214414-004 SELEXIPAG 0.8MG TABLET / ORAL AB 2023-10-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214414-005 SELEXIPAG 1.4MG TABLET / ORAL AB 2023-10-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214414-006 SELEXIPAG 1.6MG TABLET / ORAL AB 2023-10-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214414-001 SELEXIPAG 0.2MG TABLET / ORAL AB 2023-10-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214414-002 SELEXIPAG 0.4MG TABLET / ORAL AB 2023-10-11 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 138 observed states.
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table 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 Name fallback generic name: SELEXIPAG
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 69857 ORIG 2022-01-12