Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020799
Company: DAIICHI
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FLOXIN OTIC | OFLOXACIN | 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OTIC | Discontinued | None | Yes | No |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 |