Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062682
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VANCOLED VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No
VANCOLED VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No
VANCOLED VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/VIAL **Federal Register determination that product was discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No
VANCOLED VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No
VANCOLED VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No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
07/22/1986 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
10/23/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/05/1995 SUPPL-13 Labeling

Label is not available on this site.

03/10/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/22/1991 SUPPL-11 Labeling

Label is not available on this site.

03/05/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/09/1991 SUPPL-8 Labeling

Label is not available on this site.

03/01/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/30/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/11/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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