Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063321
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VANCOLED VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE/5ML FOR SOLUTION;ORAL Discontinued None No No
VANCOLED VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/6ML FOR SOLUTION;ORAL 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
10/15/1993 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
01/29/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/04/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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