Home Applications 021779 Application 021779
Type NDA
Sponsor ACTELION PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VENTAVIS ILOPROST SOLUTION;INHALATION 20MCG/2ML (10MCG/ML) No No 002 VENTAVIS ILOPROST SOLUTION;INHALATION 10MCG/ML (10MCG/ML) Yes Yes 003 VENTAVIS ILOPROST SOLUTION;INHALATION 20MCG/ML (20MCG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021779-001 VENTAVIS ILOPROST 20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION 2004-12-29 N021779-002 VENTAVIS ILOPROST 10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2005-12-08 N021779-003 VENTAVIS ILOPROST 20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2009-08-07
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 4 · 126 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 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION 2004-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2005-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2009-08-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION 2004-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2005-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2009-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION 2004-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2005-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2009-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION 2004-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2005-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2009-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021779-002 VENTAVIS 10MCG/ML (10MCG/ML) SOLUTION / INHALATION RLD 2005-12-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021779-003 VENTAVIS 20MCG/ML (20MCG/ML) SOLUTION / INHALATION RLD 2009-08-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021779-001 VENTAVIS 20MCG/2ML (10MCG/ML) SOLUTION / INHALATION 2004-12-29 1e350fbaab3a…
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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66215-302 Ventavis iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-302 VENTAVIS iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-302 VENTAVIS iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-302 VENTAVIS iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-302 Ventavis iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-302 Ventavis iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-302 VENTAVIS iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-302 VENTAVIS iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-302 VENTAVIS iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-303 Ventavis iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-303 VENTAVIS iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-303 VENTAVIS iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-303 VENTAVIS iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-303 Ventavis iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-303 Ventavis iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-303 VENTAVIS iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-303 VENTAVIS iloprost Actelion Pharmaceuticals US, Inc. NDA Current 66215-303 VENTAVIS iloprost Actelion Pharmaceuticals US, Inc. NDA Current