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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020037
Company: NOVARTIS

Products on NDA 020037

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VOLTAREN	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020037

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.

Labels for NDA 020037

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

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