Drugs@FDA: FDA-Approved Drugs

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

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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