Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050628
Company: EYEVANCE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBRASONE FLUOROMETHOLONE ACETATE; TOBRAMYCIN 0.1%;0.3% SUSPENSION/DROPS;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
07/21/1989 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
12/11/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/07/2001 SUPPL-1 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50628S1lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/07/2001 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50628S1lbl.pdf

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