Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020037
Company: NOVARTIS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VOLTAREN DICLOFENAC SODIUM 0.1% SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/28/1991 ORIG-1 Approval Type 3 - New Dosage Form 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
09/13/2012 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020037s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020037Orig1s031ltr.pdf
04/08/2011 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020037s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020037s023ltr.pdf
10/01/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
04/09/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
10/12/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
09/04/2007 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020037s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020037s014ltr.pdf
12/26/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
10/27/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
08/05/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
02/25/1998 SUPPL-8 Efficacy-New Indication

Label is not available on this site.
07/23/1996 SUPPL-7 Efficacy-New Indication

Label is not available on this site.
11/19/1997 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/03/1995 SUPPL-5 Labeling

Label is not available on this site.
03/15/1995 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/15/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
12/08/1992 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/09/1992 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/13/2012 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020037s031lbl.pdf
04/08/2011 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020037s023lbl.pdf
09/04/2007 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020037s014lbl.pdf

VOLTAREN

SOLUTION/DROPS;OPHTHALMIC; 0.1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOFENAC SODIUM DICLOFENAC SODIUM 0.1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077845 AKORN
DICLOFENAC SODIUM DICLOFENAC SODIUM 0.1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 203383 ALTAIRE PHARMS INC
DICLOFENAC SODIUM DICLOFENAC SODIUM 0.1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078792 BAUSCH AND LOMB
DICLOFENAC SODIUM DICLOFENAC SODIUM 0.1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078553 RISING
DICLOFENAC SODIUM DICLOFENAC SODIUM 0.1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078031 SANDOZ INC
VOLTAREN DICLOFENAC SODIUM 0.1% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 020037 NOVARTIS

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