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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 Speclt 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-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

Summary for NDA: 020950

Tradename:
DUONEB
Applicant:
Mylan Speclt
Ingredient:
albuterol sulfate; ipratropium bromide
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%
Approval Date:Mar 21, 2001TE:RLD:No
Patent:6,632,842Patent 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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