Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219920
Company: AVYXA HOLDINGS

Products on NDA 219920

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AVGEMSI	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
AVGEMSI	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
AVGEMSI	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 219920

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2025	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219920Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219920Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/27/2025	SUPPL-1			Label is not available on this site.

Labels for NDA 219920

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/27/2025	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219920Orig1s000lbl.pdf