Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062716
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 INJECTABLE;INJECTION Discontinued None No No
VANCOCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL 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
03/13/1987 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
04/11/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/02/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/04/1994 SUPPL-11 Labeling

Label is not available on this site.

10/30/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/24/1995 SUPPL-9 Labeling

Label is not available on this site.

05/24/1995 SUPPL-6 Labeling

Label is not available on this site.

05/18/1992 SUPPL-5 Labeling

Label is not available on this site.

05/18/1992 SUPPL-2 Labeling

Label is not available on this site.

07/22/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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