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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202813
Company: TEVA BRANDED PHARM

Summary Review

Products on NDA 202813

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QNASL	BECLOMETHASONE DIPROPIONATE	0.08MG/ACTUATION	AEROSOL, METERED;NASAL	Prescription	None	Yes	Yes
QNASL	BECLOMETHASONE DIPROPIONATE	0.04MG/ACTUATION	AEROSOL, METERED;NASAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202813

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2012	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202813s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202813s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202813_qnasl_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202813Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/30/2018	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202813Orig1s012lbl.pdf
07/26/2017	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202813s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202813Orig1s011ltr.pdf
02/29/2016	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/17/2014	SUPPL-9	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s007,s009ltr.pdf
02/03/2015	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/17/2014	SUPPL-7	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s007,s009ltr.pdf
07/10/2014	SUPPL-6	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s006ltr.pdf
03/19/2014	SUPPL-5	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s005ltr.pdf
03/09/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/29/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 202813

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/30/2018	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202813Orig1s012lbl.pdf
07/26/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202813s011lbl.pdf
07/26/2017	SUPPL-11	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202813s011lbl.pdf
12/17/2014	SUPPL-9	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s007s009lbl.pdf
12/17/2014	SUPPL-7	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s007s009lbl.pdf
03/19/2014	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s005lbl.pdf
03/23/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202813s000lbl.pdf

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