Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017869
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUNDUSCEIN-25 FLUORESCEIN SODIUM 25% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
11/10/1976 ORIG-1 Approval Type 1 - New Molecular Entity 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
02/14/1996 SUPPL-5 Labeling

Label is not available on this site.

08/25/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/25/1987 SUPPL-3 Labeling

Label is not available on this site.

09/15/1982 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/27/1980 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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