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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020911
Company: TEVA BRANDED PHARM

Patient Information Sheet

Products on NDA 020911

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QVAR 40	BECLOMETHASONE DIPROPIONATE	0.04MG/INH Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, METERED;INHALATION	Discontinued	None	Yes	No
QVAR 80	BECLOMETHASONE DIPROPIONATE	0.08MG/INH Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AEROSOL, METERED;INHALATION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020911

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_QVAR_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_QVAR_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_Qvar.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2017	SUPPL-30	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020911Orig1s029,s030ltr.pdf
09/29/2017	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020911Orig1s029,s030ltr.pdf
12/16/2015	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
05/22/2014	SUPPL-26	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020911Origs026ltr.pdf
07/21/2014	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020911Orig1s025ltr.pdf
03/09/2015	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
05/08/2013	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
07/30/2012	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020911s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020911Orig1s022ltr.pdf
08/18/2008	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020911s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020911s017ltr.pdf
11/20/2006	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020911s015_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020911s015_ltr.pdf
08/01/2003	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20911slr008ltr.pdf
07/11/2002	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
01/17/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
05/10/2002	SUPPL-5	Efficacy-New Patient Population	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20911s005ltr.pdf
08/02/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
04/17/2001	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/27/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
02/01/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020911

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2017	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf
09/29/2017	SUPPL-30	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf
09/29/2017	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf
07/21/2014	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s025lbl.pdf
05/22/2014	SUPPL-26	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s026lbl.pdf
07/30/2012	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020911s022lbl.pdf
08/18/2008	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020911s017lbl.pdf
11/20/2006	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020911s015_LBL.pdf
09/15/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_QVAR_Prntlbl.pdf

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