Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018988
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VASOCIDIN PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM EQ 0.23% PHOSPHATE;10% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No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
08/26/1988 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/26/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/07/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1995 SUPPL-6 Labeling

Label is not available on this site.

05/09/1996 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1992 SUPPL-3 Labeling

Label is not available on this site.

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