Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216457
Company: HERON THERAPS INC

Products on NDA 216457

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APONVIE	APREPITANT	32MG/4.4ML (7.2MG/ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216457

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/16/2022	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216457s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216457Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216457Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2024	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216457Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216457Orig1s003ltr.pdf

Labels for NDA 216457

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216457Orig1s003lbl.pdf
03/05/2024	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216457Orig1s003lbl.pdf
09/16/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216457s000lbl.pdf