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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206099
Company: CURRAX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONZETRA XSAIL SUMATRIPTAN SUCCINATE EQ 11MG BASE POWDER;NASAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/27/2016 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206099s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206099Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206099Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2019 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206099s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206099Orig1s006ltr.pdf
06/18/2019 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206099s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206099Orig1s005ltr.pdf
11/16/2016 SUPPL-1 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
12/20/2019 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206099s006lbl.pdf
06/18/2019 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206099s005lbl.pdf
01/27/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206099s000lbl.pdf
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