Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065401
Company: PHARM ASSOC

Products on ANDA 065401

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065401

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2008	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2021	SUPPL-16	Labeling-Patient Package Insert		Label is not available on this site.
10/19/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
10/19/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/19/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/26/2013	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/23/2009	SUPPL-2	Labeling		Label is not available on this site.