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Details for New Drug Application (NDA): 020949

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NDA 020949 describes ACCUNEB, which is a drug marketed by Mylan Speclt and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ACCUNEB profile page.

The generic ingredient in ACCUNEB is albuterol sulfate. There are thirty-six drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

Summary for NDA: 020949

Tradename:
ACCUNEB
Applicant:
Mylan Speclt
Ingredient:
albuterol sulfate
Patents:1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020949

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 020949

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACCUNEB
albuterol sulfate
SOLUTION;INHALATION 020949 NDA Mylan Pharmaceuticals Inc. 0378-6991 0378-6991-52 5 POUCH in 1 CARTON (0378-6991-52) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL
ACCUNEB
albuterol sulfate
SOLUTION;INHALATION 020949 NDA Mylan Pharmaceuticals Inc. 0378-6992 0378-6992-52 5 POUCH in 1 CARTON (0378-6992-52) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Apr 30, 2001TE:ANRLD:Yes
Patent:6,702,997Patent Expiration:Dec 28, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:INDICATED FOR THE RELIEF OF BRONCHOSPASM IN PATIENTS 2-12 YEARS OF AGE WITH ASTHMA (REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Apr 30, 2001TE:ANRLD:Yes
Patent:6,702,997Patent Expiration:Dec 28, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:INDICATED FOR THE RELIEF OF BRONCHOSPASM IN PATIENTS 2-12 YEARS OF AGE WITH ASTHMA (REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE)


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