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-three 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 Action	Adrenergic 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:	RX	Dosage:	POWDER, METERED;INHALATION			Strength	EQ 0.09MG BASE/INH
Approval Date:	Mar 31, 2015	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	May 18, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	May 18, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Jan 1, 2032	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 205636

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

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