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Last Updated: March 19, 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-two 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
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 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:⤷  Try a TrialPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent 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 RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm PROAIR DIGIHALER albuterol sulfate POWDER, METERED;INHALATION 205636-002 Dec 21, 2018 ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm PROAIR DIGIHALER albuterol sulfate POWDER, METERED;INHALATION 205636-002 Dec 21, 2018 ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm PROAIR DIGIHALER albuterol sulfate POWDER, METERED;INHALATION 205636-002 Dec 21, 2018 ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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