Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050486
Company: PARKEDALE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIRA-A VIDARABINE 3% OINTMENT;OPHTHALMIC 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
11/26/1976 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/26/1999 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1998 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/04/1997 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1997 SUPPL-14 Labeling

Label is not available on this site.

08/27/1996 SUPPL-13 Labeling

Label is not available on this site.

12/12/1977 SUPPL-12 Labeling

Label is not available on this site.

08/04/1997 SUPPL-11 Labeling

Label is not available on this site.

04/29/1981 SUPPL-10 Labeling

Label is not available on this site.

01/22/1980 SUPPL-8 Labeling

Label is not available on this site.

12/20/1979 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/05/1978 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/15/1978 SUPPL-5 Labeling

Label is not available on this site.

11/15/1977 SUPPL-3 Labeling

Label is not available on this site.

07/01/1977 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/22/1976 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

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