Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022445
Company: HERON THERAPS INC

• Medication Guide

Products on NDA 022445

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUSTOL	GRANISETRON	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022445

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/09/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022445s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022445Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/022445Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2023	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022445s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022445Orig1s010ltr.pdf

Labels for NDA 022445

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2023	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022445s010lbl.pdf
05/25/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022445s010lbl.pdf
08/09/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022445s000lbl.pdf