An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	AB	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.html

Supplements

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

Therapeutic Equivalents for NDA 216457

APONVIE

EMULSION;INTRAVENOUS; 32MG/4.4ML (7.2MG/ML)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APONVIE	APREPITANT	32MG/4.4ML (7.2MG/ML)	EMULSION;INTRAVENOUS	Prescription	Yes	AB	216457	HERON THERAPS INC

Top