Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 014169
Company: ALCON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DENDRID IDOXURIDINE 0.1% 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
06/28/1963 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
07/26/1994 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1985 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/30/1979 SUPPL-10 Labeling

Label is not available on this site.

08/22/1977 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1977 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

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