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Last Updated: November 2, 2024

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 two suppliers. There are nine 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-eight drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
Summary for 205636
Tradename:PROAIR RESPICLICK
Applicant:Teva Branded Pharm
Ingredient:albuterol sulfate
Patents:21
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 DIGIHALER albuterol sulfate POWDER, METERED;INHALATION 205636 NDA RPK Pharmaceuticals, Inc. 53002-1750 53002-1750-1 1 INHALER in 1 BOX (53002-1750-1) / 200 POWDER, METERED in 1 INHALER
PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636 NDA RPK Pharmaceuticals, Inc. 53002-1750 53002-1750-1 1 INHALER in 1 BOX (53002-1750-1) / 200 POWDER, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER, METERED;INHALATIONStrengthEQ 0.09MG BASE/INH
Approval Date:Mar 31, 2015TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jan 1, 2032Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 205636

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm PROAIR DIGIHALER albuterol sulfate POWDER, METERED;INHALATION 205636-002 Dec 21, 2018 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR DIGIHALER albuterol sulfate POWDER, METERED;INHALATION 205636-002 Dec 21, 2018 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.