Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020569
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VITRASERT GANCICLOVIR 4.5MG IMPLANT;IMPLANTATION 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
03/04/1996 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/18/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1997 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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