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Generated: December 14, 2018

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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 two suppliers. There are twelve 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-eight 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:12
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 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 Teva Respiratory, LLC 59310-580 59310-580-20 1 INHALER in 1 BOX (59310-580-20) > 200 POWDER, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER, METERED;INHALATIONStrengthEQ 0.090MG BASE/INH
Approval Date:Mar 31, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 28, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Mar 12, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?

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