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Drugs@FDA: FDA-Approved Drugs

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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VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER;INTRAVENOUS	Discontinued	None	Yes	No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	None	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

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.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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
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 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	217489	HIKMA
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	209481	MYLAN LABS LTD

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	217489	HIKMA
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	209481	MYLAN LABS LTD

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