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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209296
Company: HERON THERAPS INC

Products on NDA 209296

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CINVANTI	APREPITANT	130MG/18ML (7.2MG/ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209296

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/2017	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209296s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209296Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209296Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2024	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209296Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209296Orig1s015ltr.pdf
03/14/2022	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209296Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209296Orig1s008ltr.pdf
10/21/2019	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209296s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209296Orig1s004ltr.pdf
02/26/2019	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209296s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209296Orig1s003ltr.pdf

Labels for NDA 209296

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2024	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209296Orig1s015lbl.pdf
03/05/2024	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209296Orig1s015lbl.pdf
03/14/2022	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209296Orig1s008lbl.pdf
03/14/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209296Orig1s008lbl.pdf
03/14/2022	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209296Orig1s008lbl.pdf
10/21/2019	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209296s004lbl.pdf
02/26/2019	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209296s003lbl.pdf
11/09/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209296s000lbl.pdf

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