FDA.reportPublic FDA data

Application 020394

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATROVENTIPRATROPIUM BROMIDESPRAY, METERED;NASAL0.042MG/SPRAYYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020394-001ATROVENTIPRATROPIUM BROMIDE0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1995-10-20

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020394-001ATROVENT0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1995-10-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020394-001ATROVENT0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1995-10-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020394-001ATROVENT0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1995-10-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020394-001ATROVENT0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1995-10-20a50c72e98297…

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium BromideIPRATROPIUM BROMIDECardinal Health 107, LLC6b730dd7-4d93-403a-bfd2-fa0efa298b752026-07-24Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDERising Pharma Holdings, Inc.3249aea8-a395-f09f-e063-6294a90a2d8b2026-07-16Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDESportpharm LLC7e8fdd92-1e55-47e2-aa85-e48cfebbb8d72026-07-14Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDECardinal Health 107, LLC51350fab-a919-4d97-9d0c-d9dc7286244c2026-06-02Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDERedpharm Drug52c63e41-dbbc-d9d7-e063-6294a90a30c92026-05-27Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDENORTHSTAR RX LLCe592b6b5-038a-dbe8-457e-76e88a0f194a2026-02-27Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDENORTHSTAR RX LLC6493c00f-2306-2cb6-9624-4ea678f665762026-02-27Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDELupin Pharmaceuticals, Inc.13a45df5-a8e3-41d6-91f4-773255b5a04b2026-01-08Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDELupin Pharmaceuticals, Inc.ee0ac556-8a23-4d5c-a5da-881c1fc6a3392026-01-08Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDEAdvagen Pharma Ltdbb5f7711-595f-4f7c-9e89-66d029ccbccb2025-12-12Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDERitedose Pharmaceuticals, LLC22479633-624a-4251-ad3c-1dcba5d503fb2025-12-10Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDEChartwell RX, LLC1e3d4faa-cf6e-460b-b1e0-fcc8094505fa2025-12-02Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Atrovent HFAIPRATROPIUM BROMIDEBoehringer Ingelheim Pharmaceuticals, Inc.170e98ef-5560-4068-be7d-e649068eb8842025-11-05Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDEOceanside Pharmaceuticalsb1a5e41a-9100-41d5-a7d0-2e763ad5efb62025-08-06Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDENephron Pharmaceuticals Corporationdb8095db-d1fd-4099-9fb1-d1ad4e2849762025-04-08Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDEAdvagen Pharma Ltd4874e61a-5abe-4d1d-a30f-65b3e092db262025-01-29Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDEA-S Medication Solutions411ccc2c-ec30-450d-8704-b63095fd343b2025-01-22Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDENuCare Pharmaceuticals, Inc.2b9b619a-5e2a-73ef-e063-6394a90a97fe2025-01-13Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDEA-S Medication Solutions7159cf05-da58-4eb9-9e6d-a7f24eec5f462025-01-08Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDEBryant Ranch Prepack43ef9085-64e4-429a-a614-926d9a3652b72024-11-08Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23970SUPPL2011-12-16
2473SUPPL2011-02-24
24901SUPPL2008-10-21
34599SUPPL2004-09-20
24900SUPPL2003-05-30
41330SUPPL2000-10-27
41329SUPPL1998-11-09
2472SUPPL1998-11-09