Home Applications 203108 Application 203108
Type NDA
Sponsor BOEHRINGER INGELHEIM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 STRIVERDI RESPIMAT OLODATEROL HYDROCHLORIDE SPRAY, METERED;INHALATION EQ 0.0025MG BASE/INH 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 N203108-001 STRIVERDI RESPIMAT OLODATEROL HYDROCHLORIDE EQ 0.0025MG BASE/INH SPRAY, METERED / INHALATION RLD, RS 2014-07-31
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 N203108-001 7727984 2027-01-19 Drug substance 2014-08-15
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 2026-08-01 22:54:32 2026-06 N203108-001 STRIVERDI RESPIMAT EQ 0.0025MG BASE/INH SPRAY, METERED / INHALATION RLD, RS 2014-07-31 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 2026-08-01 22:54:32 2026-06 N203108-001 7727984 2027-01-19 Drug substance 2014-08-15 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0597-0192 Striverdi Respimat olodaterol respimat inhalation spray Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0192 Striverdi Respimat olodaterol respimat inhalation spray Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0192 Striverdi Respimat olodaterol respimat inhalation spray Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0192 Striverdi Respimat olodaterol respimat inhalation spray Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current