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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022524
Company: AQUESTIVE

Summary Review

Products on NDA 022524

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZUPLENZ	ONDANSETRON	4MG	FILM;ORAL	Discontinued	None	Yes	No
ZUPLENZ	ONDANSETRON	8MG	FILM;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022524

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/02/2010	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/2010/022524s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022524s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022524_zuplenz_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022524Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/05/2021	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022524s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022524Orig1s007ltr.pdf
06/25/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/18/2014	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022524s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022524Orig1s003ltr.pdf
10/30/2013	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022524s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022524Orig1s002ltr.pdf

Labels for NDA 022524

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/05/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022524s007lbl.pdf
09/18/2014	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022524s003lbl.pdf
10/30/2013	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022524s002lbl.pdf
07/02/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022524s000lbl.pdf

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