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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 076103


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NDA 076103 describes IPRATROPIUM BROMIDE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Bausch, Landela Pharm, Luoxin Aurovitas, Mylan Speciality Lp, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms Usa, Watson Labs, Zennova, Amneal, Aurobindo Pharma Usa, and Hikma, and is included in twenty-three NDAs. It is available from eighteen suppliers. Additional details are available on the IPRATROPIUM BROMIDE profile page.

The generic ingredient in IPRATROPIUM BROMIDE 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 076103
Tradename:IPRATROPIUM BROMIDE
Applicant:Bausch
Ingredient:ipratropium bromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076103
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 076103
Suppliers and Packaging for NDA: 076103
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 076103 ANDA Bausch & Lomb Incorporated 24208-399 24208-399-15 1 BOTTLE, SPRAY in 1 CARTON (24208-399-15) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY
IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 076103 ANDA RPK Pharmaceuticals, Inc. 53002-7880 53002-7880-1 165 SPRAY, METERED in 1 BOTTLE, SPRAY (53002-7880-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.042MG/SPRAY
Approval Date:Mar 31, 2003TE:ABRLD:No

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