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): 208910
Company: AZURITY

Products on NDA 208910

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FIRVANQ KIT	VANCOMYCIN HYDROCHLORIDE	EQ 25MG BASE/ML	FOR SOLUTION;ORAL	Prescription	AB	Yes	Yes
FIRVANQ KIT	VANCOMYCIN HYDROCHLORIDE	EQ 50MG BASE/ML	FOR SOLUTION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208910

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208910s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208910Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208910Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/29/2021	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208910s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208910Orig1s007ltr.pdf
02/16/2022	SUPPL-5	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208910Orig1s005ltr.pdf
12/13/2019	SUPPL-4	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208910Orig1s004ltr.pdf

Labels for NDA 208910

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/29/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208910s007lbl.pdf
01/26/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208910s000lbl.pdf

Therapeutic Equivalents for NDA 208910

FIRVANQ KIT

FOR SOLUTION;ORAL; EQ 25MG BASE/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FIRVANQ KIT	VANCOMYCIN HYDROCHLORIDE	EQ 25MG BASE/ML	FOR SOLUTION;ORAL	Prescription	Yes	AB	208910	AZURITY
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 25MG BASE/ML	FOR SOLUTION;ORAL	Prescription	No	AB	214913	ALKEM LABS LTD

FOR SOLUTION;ORAL; EQ 50MG BASE/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FIRVANQ KIT	VANCOMYCIN HYDROCHLORIDE	EQ 50MG BASE/ML	FOR SOLUTION;ORAL	Prescription	Yes	AB	208910	AZURITY
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 50MG BASE/ML	FOR SOLUTION;ORAL	Prescription	No	AB	214913	ALKEM LABS LTD

Top