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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060180
Company: STERISCIENCE

Products on ANDA 060180

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	No	No
VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 060180

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/06/1964	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
10/18/2022	SUPPL-50	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/29/2021	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/060180s049lbl.pdf
12/18/2017	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060180s048lbl.pdf
01/31/2017	SUPPL-47	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060180s047lbl.pdf
01/31/2017	SUPPL-46	Labeling-Package Insert		Label is not available on this site.
07/20/1998	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
06/24/1996	SUPPL-39	Labeling		Label is not available on this site.
04/24/1996	SUPPL-38	Labeling		Label is not available on this site.
07/01/1996	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
01/12/1995	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
01/12/1995	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
03/04/1994	SUPPL-33	Labeling		Label is not available on this site.
05/24/1995	SUPPL-32	Labeling		Label is not available on this site.
01/11/1993	SUPPL-31	Labeling		Label is not available on this site.
04/10/1990	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
02/15/1991	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 060180

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/29/2021	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/060180s049lbl.pdf
12/18/2017	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060180s048lbl.pdf
01/31/2017	SUPPL-47	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060180s047lbl.pdf

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