Home Applications 022260 Application 022260
Type NDA
Sponsor ACTELION PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VELETRI EPOPROSTENOL SODIUM INJECTABLE;INJECTION EQ 1.5MG BASE/VIAL Yes Yes 002 VELETRI EPOPROSTENOL SODIUM INJECTABLE;INJECTION EQ 0.5MG BASE/VIAL Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022260-001 VELETRI EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 N022260-002 VELETRI EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022260-001 8598227 2027-02-02 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 N022260-002 8598227 2027-02-02 N022260-002 8318802 2027-03-15 Drug product
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 1 of 3 · 84 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 2026-08-18 06:07:40 2026-07 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD 2012-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2012-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2012-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2012-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2008-06-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION RLD 2012-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022260-001 VELETRI EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2008-06-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022260-002 VELETRI EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RLD, RS 2012-06-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Observed Orange Book patent history# Patent history page 1 of 5 · 168 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N022260-001 8598227 2027-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022260-002 8598227 2027-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022260-002 8318802 2027-03-15 Drug product caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022260-001 8598227 2027-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022260-002 8598227 2027-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022260-002 8318802 2027-03-15 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022260-001 8598227 2027-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022260-002 8598227 2027-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022260-002 8318802 2027-03-15 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022260-001 8598227 2027-02-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022260-002 8598227 2027-02-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022260-002 8318802 2027-03-15 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022260-001 8598227 2027-02-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022260-002 8598227 2027-02-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022260-002 8318802 2027-03-15 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022260-001 8598227 2027-02-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022260-002 8598227 2027-02-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022260-002 8318802 2027-03-15 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022260-001 8598227 2027-02-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022260-002 8598227 2027-02-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022260-002 8318802 2027-03-15 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022260-001 8598227 2027-02-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022260-002 8598227 2027-02-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022260-002 8318802 2027-03-15 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022260-001 8598227 2027-02-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022260-002 8598227 2027-02-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022260-002 8318802 2027-03-15 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022260-001 8598227 2027-02-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022260-001 8318802 2027-03-15 Drug product 2012-12-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022260-002 8598227 2027-02-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022260-002 8318802 2027-03-15 Drug product d8e5a09893c0…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66215-402 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current 66215-402 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current 66215-402 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current 66215-402 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current 66215-402 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current 66215-402 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current 66215-402 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current 66215-403 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current 66215-403 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current 66215-403 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current 66215-403 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current 66215-403 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current 66215-403 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current 66215-403 Veletri epoprostenol Actelion Pharmaceuticals US, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 65021 SUPPL 2020-10-23 64984 SUPPL 2020-10-23 56882 SUPPL 2018-12-20 56738 SUPPL 2018-12-14 48864 SUPPL 2017-06-29 17163 SUPPL 2013-06-05 38459 SUPPL 2011-04-01 7128 SUPPL 2011-04-01 38458 SUPPL 2010-09-07 29487 SUPPL 2010-08-30 44719 ORIG 2008-11-06 21972 ORIG 2008-11-06 7127 ORIG 2008-07-01