Home Applications 213947 Application 213947
Type ANDA
Sponsor NEXUS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TIROFIBAN HYDROCHLORIDE TIROFIBAN HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) No No 002 TIROFIBAN HYDROCHLORIDE TIROFIBAN HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213947-001 TIROFIBAN HYDROCHLORIDE TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 A213947-002 TIROFIBAN HYDROCHLORIDE TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 of 2 · 47 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 2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 47 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 73754 ORIG 2023-03-14