Home Applications 204410 Application 204410
Type NDA
Sponsor ACTELION PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OPSUMIT MACITENTAN TABLET;ORAL 10MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204410-001 OPSUMIT MACITENTAN 10MG TABLET / ORAL AB RLD, RS 2013-10-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N204410-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204410-001 7094781 2025-12-05 Drug substance, Drug product 2013-11-06 N204410-001 7094781*PED 2026-06-05 Pediatric extension N204410-001 10946015 2026-09-11 U-1445 Drug product 2021-04-08 N204410-001 10946015*PED 2027-03-11 Pediatric extension N204410-001 9265762 2027-05-29 U-1820 Drug product 2016-03-16 N204410-001 9265762*PED 2027-11-29 Pediatric extension N204410-001 8367685 2028-10-04 U-1445 Drug product 2013-11-06 N204410-001 8367685*PED 2029-04-04 Pediatric extension N204410-001 8268847 2029-04-18 U-1446 2013-11-06 N204410-001 8268847*PED 2029-10-18 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N204410-001 M-187 2028-02-28 N204410-001 PED 2028-08-28
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N204410-001 OPSUMIT 10MG TABLET / ORAL AB RLD, RS 2013-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204410-001 OPSUMIT 10MG TABLET / ORAL AB RLD, RS 2013-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204410-001 OPSUMIT 10MG TABLET / ORAL AB RLD, RS 2013-10-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204410-001 OPSUMIT 10MG TABLET / ORAL AB RLD, RS 2013-10-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204410-001 OPSUMIT 10MG TABLET / ORAL AB RLD, RS 2013-10-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204410-001 OPSUMIT 10MG TABLET / ORAL AB RLD, RS 2013-10-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N204410-001 OPSUMIT 10MG TABLET / ORAL RLD, RS 2013-10-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 212 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N204410-001 7094781 2025-12-05 Drug substance, Drug product 2013-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204410-001 7094781*PED 2026-06-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204410-001 10946015 2026-09-11 U-1445 Drug product 2021-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204410-001 10946015*PED 2027-03-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204410-001 9265762 2027-05-29 U-1820 Drug product 2016-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204410-001 9265762*PED 2027-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204410-001 8367685 2028-10-04 U-1445 Drug product 2013-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204410-001 8367685*PED 2029-04-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204410-001 8268847 2029-04-18 U-1446 2013-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204410-001 8268847*PED 2029-10-18 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204410-001 7094781 2025-12-05 Drug substance, Drug product 2013-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204410-001 7094781*PED 2026-06-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204410-001 10946015 2026-09-11 U-1445 Drug product 2021-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204410-001 10946015*PED 2027-03-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204410-001 9265762 2027-05-29 U-1820 Drug product 2016-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204410-001 9265762*PED 2027-11-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204410-001 8367685 2028-10-04 U-1445 Drug product 2013-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204410-001 8367685*PED 2029-04-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204410-001 8268847 2029-04-18 U-1446 2013-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204410-001 8268847*PED 2029-10-18 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204410-001 7094781 2025-12-05 Drug substance, Drug product 2013-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204410-001 10946015 2026-09-11 U-1445 Drug product 2021-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204410-001 9265762 2027-05-29 U-1820 Drug product 2016-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204410-001 8367685 2028-10-04 U-1445 Drug product 2013-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204410-001 8268847 2029-04-18 U-1446 2013-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204410-001 7094781 2025-12-05 Drug substance, Drug product 2013-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204410-001 10946015 2026-09-11 U-1445 Drug product 2021-04-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204410-001 9265762 2027-05-29 U-1820 Drug product 2016-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204410-001 8367685 2028-10-04 U-1445 Drug product 2013-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204410-001 8268847 2029-04-18 U-1446 2013-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204410-001 7094781 2025-12-05 Drug substance, Drug product 2013-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204410-001 10946015 2026-09-11 U-1445 Drug product 2021-04-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204410-001 9265762 2027-05-29 U-1820 Drug product 2016-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204410-001 8367685 2028-10-04 U-1445 Drug product 2013-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204410-001 8268847 2029-04-18 U-1446 2013-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204410-001 7094781 2025-12-05 Drug substance, Drug product 2013-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204410-001 10946015 2026-09-11 U-1445 Drug product 2021-04-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204410-001 9265762 2027-05-29 U-1820 Drug product 2016-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204410-001 8367685 2028-10-04 U-1445 Drug product 2013-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204410-001 8268847 2029-04-18 U-1446 2013-11-06 03ed91905a0d…
Observed Orange Book exclusivity history# 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 OPSUMIT MACITENTAN Actelion Pharmaceuticals US, Inc. 1e484a50-55db-4b85-8c57-6cd1b0353abd 2025-04-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 204410 application number: NDA204410 ndc (product): 66215-501
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66215-501 OPSUMIT macitentan Actelion Pharmaceuticals US, Inc. NDA Current 66215-501 OPSUMIT macitentan Actelion Pharmaceuticals US, Inc. NDA Current 66215-501 OPSUMIT macitentan Actelion Pharmaceuticals US, Inc. NDA Current 66215-501 OPSUMIT macitentan Actelion Pharmaceuticals US, Inc. NDA Current 66215-501 OPSUMIT macitentan Actelion Pharmaceuticals US, Inc. NDA Current 66215-501 OPSUMIT macitentan Actelion Pharmaceuticals US, Inc. NDA Current 66215-501 OPSUMIT macitentan Actelion Pharmaceuticals US, Inc. NDA Current