Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062812
Company: ANI PHARMS INC
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VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No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VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No
VANCOCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/17/1987 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
07/12/2017 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

07/12/2017 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

07/12/2017 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

04/24/1996 SUPPL-23 Labeling

Label is not available on this site.

06/20/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/04/1994 SUPPL-20 Labeling

Label is not available on this site.

01/12/1993 SUPPL-19 Labeling

Label is not available on this site.

11/08/1991 SUPPL-18 Labeling

Label is not available on this site.

11/03/1992 SUPPL-13 Labeling

Label is not available on this site.

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