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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021457
Company: TEVA BRANDED PHARM

Exclusivity Letter

Products on NDA 021457

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROAIR HFA	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	AB2	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021457

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21457lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21457ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021457s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2019	SUPPL-36	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021457s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021457Orig1s036ltr.pdf
05/20/2016	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
01/08/2014	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
03/23/2013	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
01/09/2013	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
12/10/2012	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
03/07/2012	SUPPL-26	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021457s026lbl.pdf
12/10/2010	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
12/08/2010	SUPPL-22	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021457s022ltr.pdf
08/17/2010	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021457s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021457s021ltr.pdf
09/16/2008	SUPPL-13	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021457s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021457s013ltr.pdf
11/21/2005	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021457s002,004ltr.pdf
02/03/2006	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021457s003lbl.pdf
11/21/2005	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021457s002,004ltr.pdf
05/02/2005	SUPPL-1	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021457s001ltr.pdf

Labels for NDA 021457

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2019	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021457s036lbl.pdf
03/07/2012	SUPPL-26	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021457s026lbl.pdf
08/17/2010	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021457s021lbl.pdf
09/16/2008	SUPPL-13	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021457s013lbl.pdf
02/03/2006	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021457s003lbl.pdf
11/21/2005	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf
11/21/2005	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf
05/02/2005	SUPPL-1	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s001lbl.pdf
10/29/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21457lbl.pdf

Therapeutic Equivalents for NDA 021457

PROAIR HFA

AEROSOL, METERED;INHALATION; EQ 0.09MG BASE/INH
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB2	211600	AMNEAL IRELAND LTD
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB2	212447	ARMSTRONG PHARMS
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB2	209954	LUPIN
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	No	AB2	203760	PADAGIS US
PROAIR HFA	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	Yes	AB2	021457	TEVA BRANDED PHARM

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