Home Applications 211135 Application 211135
Type ANDA
Sponsor MSN LABORATORIES PRIVATE LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RIOCIGUAT RIOCIGUAT TABLET;ORAL 0.5MG No No 002 RIOCIGUAT RIOCIGUAT TABLET;ORAL 1MG No No 003 RIOCIGUAT RIOCIGUAT TABLET;ORAL 1.5MG No No 004 RIOCIGUAT RIOCIGUAT TABLET;ORAL 2MG No No 005 RIOCIGUAT RIOCIGUAT TABLET;ORAL 2.5MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211135-001 RIOCIGUAT RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 A211135-002 RIOCIGUAT RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 A211135-003 RIOCIGUAT RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 A211135-004 RIOCIGUAT RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 A211135-005 RIOCIGUAT RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 1 of 4 · 135 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 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211135-001 RIOCIGUAT 0.5MG TABLET / ORAL AB 2022-09-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211135-002 RIOCIGUAT 1MG TABLET / ORAL AB 2022-09-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211135-003 RIOCIGUAT 1.5MG TABLET / ORAL AB 2022-09-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211135-004 RIOCIGUAT 2MG TABLET / ORAL AB 2022-09-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211135-005 RIOCIGUAT 2.5MG TABLET / ORAL AB 2022-09-01 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 135 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 Riociguat RIOCIGUAT Zydus Pharmaceuticals USA Inc 8092c64b-e240-43c3-9d2e-e0dd7708d96f 2026-07-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211135 application number: ANDA211135
Documents# Document, Submission type, Date table Document Submission type Date 76282 ORIG 2023-11-03 65857 ORIG 2021-01-07