Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020809
Company: FALCON PHARMS

Products on NDA 020809

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020809

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20809lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20809ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20809A_Diclofenac.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
03/16/2001	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
02/18/2000	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/17/1999	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/17/1999	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
10/06/1999	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
02/05/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/02/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020809

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/04/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20809lbl.pdf