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Atrovent

These highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004

Approved
Approval ID

170e98ef-5560-4068-be7d-e649068eb884

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 5, 2023

Manufacturers
FDA

Boehringer Ingelheim Pharmaceuticals, Inc.

DUNS: 603175944

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ipratropium bromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0597-0087
Application NumberNDA021527
Product Classification
M
Marketing Category
C73594
G
Generic Name
ipratropium bromide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 5, 2023
FDA Product Classification

INGREDIENTS (1)

IPRATROPIUM BROMIDEActive
Quantity: 17 ug in 1 1
Code: J697UZ2A9J
Classification: ACTIR

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Atrovent - FDA Drug Approval Details