Home Applications 213218 Application 213218
Type NDA
Sponsor SARFEZ PHARMACEUTICALS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SOAANZ TORSEMIDE TABLET; ORAL 20MG No No 002 SOAANZ TORSEMIDE TABLET; ORAL 60MG No No 003 SOAANZ TORSEMIDE TABLET;ORAL 40MG Yes No
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 N213218-001 SOAANZ TORSEMIDE 20MG TABLET / ORAL RLD 2021-06-14 N213218-002 SOAANZ TORSEMIDE 60MG TABLET / ORAL RLD 2021-06-14 N213218-003 SOAANZ TORSEMIDE 40MG TABLET / ORAL RLD 2021-11-17
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213218-001 10154963 2033-10-06 Drug product 2021-09-07 N213218-002 10154963 2033-10-06 Drug product 2021-09-07
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 3 · 102 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 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213218-002 SOAANZ 60MG TABLET / ORAL RLD 2021-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213218-003 SOAANZ 40MG TABLET / ORAL RLD 2021-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213218-002 SOAANZ 60MG TABLET / ORAL RLD 2021-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213218-003 SOAANZ 40MG TABLET / ORAL RLD 2021-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213218-002 SOAANZ 60MG TABLET / ORAL RLD 2021-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213218-003 SOAANZ 40MG TABLET / ORAL RLD 2021-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213218-002 SOAANZ 60MG TABLET / ORAL RLD 2021-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213218-003 SOAANZ 40MG TABLET / ORAL RLD 2021-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213218-002 SOAANZ 60MG TABLET / ORAL RLD 2021-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213218-003 SOAANZ 40MG TABLET / ORAL RLD 2021-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213218-002 SOAANZ 60MG TABLET / ORAL RLD 2021-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213218-003 SOAANZ 40MG TABLET / ORAL RLD 2021-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213218-002 SOAANZ 60MG TABLET / ORAL RLD 2021-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213218-003 SOAANZ 40MG TABLET / ORAL RLD 2021-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213218-002 SOAANZ 60MG TABLET / ORAL RLD 2021-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213218-003 SOAANZ 40MG TABLET / ORAL RLD 2021-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213218-002 SOAANZ 60MG TABLET / ORAL RLD 2021-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213218-003 SOAANZ 40MG TABLET / ORAL RLD 2021-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213218-002 SOAANZ 60MG TABLET / ORAL RLD 2021-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213218-003 SOAANZ 40MG TABLET / ORAL RLD 2021-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213218-002 SOAANZ 60MG TABLET / ORAL RLD 2021-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213218-003 SOAANZ 40MG TABLET / ORAL RLD 2021-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213218-002 SOAANZ 60MG TABLET / ORAL RLD 2021-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213218-003 SOAANZ 40MG TABLET / ORAL RLD 2021-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213218-002 SOAANZ 60MG TABLET / ORAL RLD 2021-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213218-003 SOAANZ 40MG TABLET / ORAL RLD 2021-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213218-001 SOAANZ 20MG TABLET / ORAL RLD 2021-06-14 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 2 · 68 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 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213218-001 10154963 2033-10-06 Drug product 2021-09-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N213218-002 10154963 2033-10-06 Drug product 2021-09-07 782e0a99824c…
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73502-286 SOAANZ Torsemide Sarfez Pharmaceuticals Inc NDA Current 73502-287 SOAANZ Torsemide Sarfez Pharmaceuticals Inc NDA Current 73502-288 SOAANZ Torsemide Sarfez Pharmaceuticals Inc NDA Current 73502-586 SOAANZ Torsemide Sarfez Pharmaceuticals Inc NDA Current 73502-687 SOAANZ Torsemide Sarfez Pharmaceuticals Inc NDA Current 73502-786 SOAANZ Torsemide Sarfez Pharmaceuticals Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 71069 ORIG 2022-05-16 69910 SUPPL 2022-01-19 67826 ORIG 2021-06-15 67820 ORIG 2021-06-15