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Details for New Drug Application (NDA): 020394

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NDA 020394 describes ATROVENT, which is a drug marketed by Boehringer Ingelheim and is included in five NDAs. It is available from three suppliers. There are three patents protecting this drug. Additional details are available on the ATROVENT profile page.

The generic ingredient in ATROVENT is ipratropium bromide. There are seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.

Summary for NDA: 020394

Boehringer Ingelheim
ipratropium bromide
Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 020394

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 020394

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ipratropium bromide
SPRAY, METERED;NASAL 020394 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0086 0597-0086-76 1 BOTTLE, PUMP in 1 CARTON (0597-0086-76) > 165 SPRAY, METERED in 1 BOTTLE, PUMP
ipratropium bromide
SPRAY, METERED;NASAL 020394 NDA REMEDYREPACK INC. 52125-949 52125-949-15 15 SPRAY, METERED in 1 BOTTLE, PUMP (52125-949-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.042MG/SPRAY
Approval Date:Oct 20, 1995TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020394

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
ipratropium bromide
SPRAY, METERED;NASAL020394-001Oct 20, 19954,385,048► subscribe
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