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): 209481
Company: MYLAN LABS LTD

Products on NDA 209481

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER;INTRAVENOUS	Discontinued	None	Yes	No
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	Yes	Yes
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	Yes	Yes
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	Yes	Yes
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.75GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 2GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209481

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209481s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209481Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209481Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/26/2024	SUPPL-24	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209481s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209481Orig1s024ltr.pdf
04/04/2022	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209481s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209481Orig1s016ltr.pdf
01/29/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209481s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209481Orig1s012ltr.pdf
08/09/2019	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209481s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209481Orig1s005ltr.pdf

Labels for NDA 209481

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/26/2024	SUPPL-24	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209481s024lbl.pdf
04/04/2022	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209481s016lbl.pdf
01/29/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209481s012lbl.pdf
08/09/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209481s005lbl.pdf
07/10/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209481s000lbl.pdf

Therapeutic Equivalents for NDA 209481

VANCOMYCIN HYDROCHLORIDE

POWDER;INTRAVENOUS; EQ 750MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	218140	GLAND
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	209481	MYLAN LABS LTD
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	215324	STERISCIENCE

POWDER;INTRAVENOUS; EQ 1.25GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	217401	EUGIA PHARMA
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	218140	GLAND
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	217489	HIKMA
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	209481	MYLAN LABS LTD
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	215324	STERISCIENCE

POWDER;INTRAVENOUS; EQ 1.5GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	217401	EUGIA PHARMA
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	218140	GLAND
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	217489	HIKMA
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	209481	MYLAN LABS LTD
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	215324	STERISCIENCE

Top