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Generated: September 24, 2017

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Details for New Drug Application (NDA): 020950

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NDA 020950 describes DUONEB, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the DUONEB profile page.

The generic ingredient in DUONEB is albuterol sulfate; ipratropium bromide. There are thirty-seven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

Summary for NDA: 020950

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 020950

Suppliers and Packaging for NDA: 020950

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUONEB
albuterol sulfate; ipratropium bromide
SOLUTION;INHALATION 020950 NDA Eon Labs, Inc. 0185-7322 0185-7322-13 30 POUCH in 1 CARTON (0185-7322-13) > 1 VIAL in 1 POUCH > 3 mL in 1 VIAL
DUONEB
albuterol sulfate; ipratropium bromide
SOLUTION;INHALATION 020950 NDA Eon Labs, Inc. 0185-7322 0185-7322-30 6 POUCH in 1 CARTON (0185-7322-30) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATIONStrengthEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 21, 2001TE:RLD:Yes
Patent:► SubscribePatent Expiration:Dec 28, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD IN PATIENTS REQUIRING MORE THAN ONE BRONCHO DILATOR


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Serving 500+ biopharmaceutical companies globally:

Citi
Federal Trade Commission
Cerilliant
US Army
Moodys
Harvard Business School
UBS
Teva
Fish and Richardson
McKinsey

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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