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Details for New Drug Application (NDA): 076664

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NDA 076664 describes IPRATROPIUM BROMIDE, which is a drug marketed by Bausch And Lomb, Pharmascience Inc, Actavis Mid Atlantic, Teva Pharms Usa, Apotex Inc, Aurobindo Pharma Ltd, Mylan Speclt, Nephron, Roxane, Landela Pharm, Watson Labs, and Ritedose Corp, and is included in twenty 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-one suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.

Summary for NDA: 076664

Tradename:
IPRATROPIUM BROMIDE
Applicant:
Roxane
Ingredient:
ipratropium bromide
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076664

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 076664

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IPRATROPIUM BROMIDE
ipratropium bromide
SPRAY, METERED;NASAL 076664 ANDA West-Ward Pharmaceuticals Corp. 0054-0045 0054-0045-44 1 BOTTLE, SPRAY in 1 CARTON (0054-0045-44) > 345 SPRAY in 1 BOTTLE, SPRAY

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.021MG/SPRAY
Approval Date:Nov 5, 2003TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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