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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206099
Company: CURRAX

Products on NDA 206099

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206099

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.html

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.

Labels for NDA 206099

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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