Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 060180
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VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No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VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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