An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.cfm

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	209954	LUPIN
PROAIR HFA	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	Yes	AB2	021457	TEVA BRANDED PHARM

Top