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Serving leading biopharmaceutical companies globally:

Chubb
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Dow
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020949

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NDA 020949 describes ACCUNEB, which is a drug marketed by Mylan Speciality Lp 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-seven drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

Summary for 020949

Tradename:1
Applicant:1
Ingredient:1
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:► SubscribePatent 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:► SubscribePatent 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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Serving leading biopharmaceutical companies globally:

Deloitte
Merck
Cerilliant
Citi
Colorcon
Baxter
Teva
Cantor Fitzgerald
Moodys
Chubb

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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