Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020474
Company: EYEVANCE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VEXOL RIMEXOLONE 1% 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
12/30/1994 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
02/22/2012 SUPPL-21 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020474s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020474s021ltr.pdf
10/18/2007 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020474s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020474s019ltr.pdf
04/17/2003 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20474slr016_vexol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20474slr016ltr.pdf
03/16/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/2000 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/18/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/17/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/05/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/1998 SUPPL-7 Labeling

Label is not available on this site.

11/09/1999 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/26/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/01/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/20/1998 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1996 SUPPL-2 Labeling

Label is not available on this site.

05/10/1995 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/22/2012 SUPPL-21 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020474s021lbl.pdf
10/18/2007 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020474s019lbl.pdf
04/17/2003 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20474slr016_vexol_lbl.pdf

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