Home Applications 021527 Application 021527
Type NDA
Sponsor BOEHRINGER INGELHEIM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ATROVENT HFA IPRATROPIUM BROMIDE AEROSOL, METERED;INHALATION 0.021MG/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 N021527-001 ATROVENT HFA IPRATROPIUM BROMIDE 0.021MG/INH AEROSOL, METERED / INHALATION AB RLD, RS 2004-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021527-001 AB
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 N021527-001 8474447 2030-01-17 Drug product, Delist requested 2015-05-28
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 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION AB RLD, RS 2004-11-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N021527-001 AB 1 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 N021527-001 8474447 2030-01-17 Drug product, Delist requested 2015-05-28 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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0597-0087 Atrovent ipratropium bromide Boehringer Ingelheim Pharmaceuticals Inc. NDA Current 0597-0087 Atrovent ipratropium bromide Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0087 Atrovent ipratropium bromide Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0087 Atrovent ipratropium bromide Boehringer Ingelheim Pharmaceuticals Inc. NDA Current 0597-0087 Atrovent ipratropium bromide Boehringer Ingelheim Pharmaceuticals Inc. NDA Current 50090-0961 Atrovent ipratropium bromide A-S Medication Solutions NDA Current 53002-8410 Atrovent ipratropium bromide RPK Pharmaceuticals, Inc. NDA Current 53002-8410 Atrovent ipratropium bromide RPK Pharmaceuticals, Inc. NDA Current