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Details for New Drug Application (NDA): 076025

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NDA 076025 describes IPRATROPIUM BROMIDE, which is a drug marketed by Bausch And Lomb, Pharmascience Inc, Actavis Mid Atlantic, Teva Pharms Usa, Apotex Inc, Mylan Speclt, Nephron, Roxane, Landela Pharm, Watson Labs, and Ritedose Corp, and is included in nineteen 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 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: 076025

Bausch And Lomb
ipratropium bromide
Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 076025

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 076025

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ipratropium bromide
SPRAY, METERED;NASAL 076025 ANDA Bausch & Lomb Incorporated 24208-398 24208-398-30 1 BOTTLE, SPRAY in 1 CARTON (24208-398-30) > 345 SPRAY, METERED in 1 BOTTLE, SPRAY
ipratropium bromide
SPRAY, METERED;NASAL 076025 ANDA Physicians Total Care, Inc. 54868-5751 54868-5751-0 1 BOTTLE, SPRAY in 1 CARTON (54868-5751-0) > 345 SPRAY, METERED in 1 BOTTLE, SPRAY

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.021MG/SPRAY
Approval Date:Mar 31, 2003TE:ABRLD:No

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