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Details for New Drug Application (NDA): 205636

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NDA 205636 describes PROAIR RESPICLICK, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the PROAIR RESPICLICK profile page.

The generic ingredient in PROAIR RESPICLICK 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: 205636

Tradename:
PROAIR RESPICLICK
Applicant:
Teva Branded Pharm
Ingredient:
albuterol sulfate
Patents:11
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 205636

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 205636

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROAIR RESPICLICK
albuterol sulfate
POWDER, METERED;INHALATION 205636 NDA Teva Respiratory, LLC 59310-580 59310-580-20 1 INHALER in 1 BOX (59310-580-20) > 200 POWDER, METERED in 1 INHALER
PROAIR RESPICLICK
albuterol sulfate
POWDER, METERED;INHALATION 205636 NDA Teva Respiratory, LLC 59310-580 59310-580-21 1 INHALER in 1 BOX (59310-580-21) > 200 POWDER, METERED in 1 INHALER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER, METERED;INHALATIONStrengthEQ 0.090MG BASE/INH
Approval Date:Mar 31, 2015TE:RLD:Yes
Patent:6,446,627Patent Expiration:Dec 18, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:6,701,917Patent Expiration:Jun 23, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:6,718,972Patent Expiration:Jun 23, 2021Product Flag?YSubstance Flag?Delist Request?


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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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