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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 061667
Company: ANI PHARMS

Products on ANDA 061667

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION;ORAL	Discontinued	None	No	No
VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 061667

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/13/1983	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/061667Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/29/2021	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
01/29/2021	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
06/20/2019	SUPPL-26		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/061667Orig1s026.pdf
09/09/1997	SUPPL-23	Labeling		Label is not available on this site.
06/20/1996	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
07/29/1993	SUPPL-20	Labeling		Label is not available on this site.
07/12/1991	SUPPL-17	Labeling		Label is not available on this site.
05/17/1991	SUPPL-14	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 061667

VANCOCIN HYDROCHLORIDE

FOR SOLUTION;ORAL; EQ 250MG BASE/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	No	AA	061667	ANI PHARMS
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	No	AA	215338	AMNEAL

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