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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020799
Company: DAIICHI

Products on NDA 020799

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLOXIN OTIC	OFLOXACIN	0.3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS;OTIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020799

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-799_Floxin.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/04/2005	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020799s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020799s016ltr.pdf
02/24/2004	SUPPL-15	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20799slr015ltr.pdf
10/07/2003	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20799slr012_floxin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20799slr012ltr.pdf
01/03/2003	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
05/07/2002	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/30/2003	SUPPL-6	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20799se2-006_floxin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20799se2-006ltr.pdf
03/16/2000	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
12/22/1999	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/30/1999	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
02/11/1999	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
03/16/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020799

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/04/2005	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020799s016lbl.pdf
10/07/2003	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20799slr012_floxin_lbl.pdf
09/30/2003	SUPPL-6	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20799se2-006_floxin_lbl.pdf

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