Home Applications 022231 Application 022231
Type NDA
Sponsor MALLINCKRODT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TERLIVAZ TERLIPRESSIN INJECTABLE;INJECTION 0.85MG No No
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 N022231-001 TERLIVAZ TERLIPRESSIN ACETATE EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022231-001 10335452 2037-04-05 U-3711 2023-10-25
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N022231-001 NCE 2027-09-14 N022231-001 ODE-406 2029-09-14
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.
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 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 a50c72e98297…
Observed Orange Book patent history# 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 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 48 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 Terlivaz TERLIPRESSIN Mallinckrodt Hospital Products Inc. 3a35b86c-f451-4fac-8499-43019e4da354 2026-06-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022231 application number: NDA022231 ndc (product): 43825-200
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 43825-200 Terlivaz Terlipressin Mallinckrodt Hospital Products Inc. NDA Current 43825-200 Terlivaz Terlipressin Mallinckrodt Hospital Products Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 73127 SUPPL 2023-01-10 73125 SUPPL 2023-01-10 72261 ORIG 2022-10-07 72086 ORIG 2022-09-15 72077 ORIG 2022-09-14