Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020799
Company: DAIICHI
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FLOXIN OTIC OFLOXACIN 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OTIC Discontinued None Yes No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
12/16/1997 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.cfm
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.

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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