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Generated: November 13, 2018

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Details for New Drug Application (NDA): 021457

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NDA 021457 describes PROAIR HFA, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from twelve suppliers. There are six patents protecting this drug. Additional details are available on the PROAIR HFA profile page.

The generic ingredient in PROAIR HFA 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 021457
Tradename:PROAIR HFA
Applicant:Teva Branded Pharm
Ingredient:albuterol sulfate
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 021457
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 021457
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457 NDA Rebel Distributors Corp 21695-851 21695-851-85 200 AEROSOL, METERED in 1 INHALER (21695-851-85)
PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 49999-908 49999-908-85 200 AEROSOL, METERED in 1 INHALER (49999-908-85)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrengthEQ 0.09MG BASE/INH
Approval Date:Oct 29, 2004TE:BXRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Sep 12, 2023Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021457

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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