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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 021527


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NDA 021527 describes ATROVENT HFA, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the ATROVENT HFA profile page.

The generic ingredient in ATROVENT HFA is ipratropium bromide. There are eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.
Summary for 021527
Tradename:ATROVENT HFA
Applicant:Boehringer Ingelheim
Ingredient:ipratropium bromide
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021527
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 021527
Suppliers and Packaging for NDA: 021527
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATROVENT HFA ipratropium bromide AEROSOL, METERED;INHALATION 021527 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0087 0597-0087-17 1 CANISTER in 1 CARTON (0597-0087-17) / 200 AEROSOL, METERED in 1 CANISTER
ATROVENT HFA ipratropium bromide AEROSOL, METERED;INHALATION 021527 NDA RPK Pharmaceuticals, Inc. 53002-8410 53002-8410-1 1 CANISTER in 1 CARTON (53002-8410-1) / 200 AEROSOL, METERED in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.021MG/INH
Approval Date:Nov 27, 2004TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jan 17, 2030Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021527

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim ATROVENT HFA ipratropium bromide AEROSOL, METERED;INHALATION 021527-001 Nov 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim ATROVENT HFA ipratropium bromide AEROSOL, METERED;INHALATION 021527-001 Nov 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim ATROVENT HFA ipratropium bromide AEROSOL, METERED;INHALATION 021527-001 Nov 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim ATROVENT HFA ipratropium bromide AEROSOL, METERED;INHALATION 021527-001 Nov 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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