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Generated: April 29, 2017

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Details for New Drug Application (NDA): 076103

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NDA 076103 describes IPRATROPIUM BROMIDE, which is a drug marketed by Sun Pharma Global, Bausch And Lomb, Pharmascience Inc, Actavis Mid Atlantic, Teva Pharms Usa, Bausch And Lomb Inc, Apotex Inc, Aurobindo Pharma Ltd, Mylan Speciality Lp, Nephron, West-ward Pharms Int, Roxane, Landela Pharm, Watson Labs, and Ritedose Corp, and is included in twenty-one NDAs. It is available from nineteen suppliers. Additional details are available on the IPRATROPIUM BROMIDE profile page.

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

Summary for NDA: 076103

Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076103

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 076103

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
SPRAY, METERED;NASAL 076103 ANDA Rebel Distributors Corp 42254-355 42254-355-15 1 BOTTLE, SPRAY in 1 CARTON (42254-355-15) > 165 SPRAY, METERED in 1 BOTTLE, SPRAY

Summary 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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