Documents
Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Application Products
001 | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | FLOXIN | OFLOXACIN |
002 | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | FLOXIN | OFLOXACIN |
003 | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | FLOXIN | OFLOXACIN |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1990-12-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1991-12-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1992-05-15 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1992-06-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1993-09-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1992-07-14 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1992-12-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1992-09-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1993-08-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1992-09-03 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1992-09-03 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 1994-07-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1993-11-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1993-11-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1993-11-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1993-12-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1995-01-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1994-08-08 | STANDARD |
LABELING; Labeling | SUPPL | 38 | AP | 1996-09-11 | STANDARD |
LABELING; Labeling | SUPPL | 39 | AP | 1997-08-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1995-09-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1995-11-09 | STANDARD |
EFFICACY; Efficacy | SUPPL | 42 | AP | 1996-12-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1996-06-28 | STANDARD |
LABELING; Labeling | SUPPL | 44 | AP | 1998-09-21 | STANDARD |
LABELING; Labeling | SUPPL | 45 | AP | 1999-12-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1999-03-25 | STANDARD |
LABELING; Labeling | SUPPL | 47 | AP | 1999-12-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1999-09-08 | STANDARD |
LABELING; Labeling | SUPPL | 49 | AP | 1999-12-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 2000-10-30 | STANDARD |
LABELING; Labeling | SUPPL | 51 | AP | 2004-03-06 | STANDARD |
LABELING; Labeling | SUPPL | 52 | AP | 2004-09-15 | STANDARD |
LABELING; Labeling | SUPPL | 53 | AP | 2004-09-15 | STANDARD |
LABELING; Labeling | SUPPL | 54 | AP | 2006-01-20 | STANDARD |
LABELING; Labeling | SUPPL | 55 | AP | 2006-06-14 | STANDARD |
LABELING; Labeling | SUPPL | 56 | AP | 2007-05-16 | STANDARD |
LABELING; Labeling | SUPPL | 57 | AP | 2007-06-19 | STANDARD |
LABELING; Labeling | SUPPL | 58 | AP | 2007-12-13 | STANDARD |
LABELING; Labeling | SUPPL | 59 | AP | 2008-10-03 | STANDARD |
LABELING; Labeling | SUPPL | 60 | AP | 2009-02-12 | STANDARD |
LABELING; Labeling | SUPPL | 61 | AP | 2011-02-25 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 22 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 30 | Null | 0 |
SUPPL | 31 | Null | 0 |
SUPPL | 32 | Null | 0 |
SUPPL | 34 | Null | 0 |
SUPPL | 35 | Null | 0 |
SUPPL | 36 | Null | 0 |
SUPPL | 38 | Null | 0 |
SUPPL | 39 | Null | 0 |
SUPPL | 40 | Null | 0 |
SUPPL | 41 | Null | 0 |
SUPPL | 42 | Null | 0 |
SUPPL | 43 | Null | 0 |
SUPPL | 44 | Null | 0 |
SUPPL | 45 | Null | 0 |
SUPPL | 46 | Null | 0 |
SUPPL | 47 | Null | 0 |
SUPPL | 48 | Null | 0 |
SUPPL | 49 | Null | 0 |
SUPPL | 50 | Null | 0 |
SUPPL | 51 | Null | 0 |
SUPPL | 52 | Null | 0 |
SUPPL | 53 | Null | 0 |
SUPPL | 54 | Null | 0 |
SUPPL | 55 | Null | 0 |
SUPPL | 56 | Null | 0 |
SUPPL | 57 | Null | 0 |
SUPPL | 58 | Null | 0 |
SUPPL | 59 | Null | 0 |
SUPPL | 60 | Null | 0 |
SUPPL | 61 | Null | 0 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 19735
[companyName] => JANSSEN PHARMS
[docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2011\/019735s061MedG.pdf"]
[products] => [{"drugName":"FLOXIN","activeIngredients":"OFLOXACIN","strength":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"FLOXIN","activeIngredients":"OFLOXACIN","strength":"300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"FLOXIN","activeIngredients":"OFLOXACIN","strength":"400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"02\/25\/2011","submission":"SUPPL-61","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019735s061lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2008","submission":"SUPPL-59","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019735s059lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2007","submission":"SUPPL-58","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019735s058lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2007","submission":"SUPPL-57","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019735s057lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2007","submission":"SUPPL-56","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019735s056lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2006","submission":"SUPPL-55","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019735s055lbl.pdf\"}]","notes":""},{"actionDate":"01\/20\/2006","submission":"SUPPL-54","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019735s054LBL.pdf\"}]","notes":""},{"actionDate":"09\/15\/2004","submission":"SUPPL-53","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19735s052,053lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2004","submission":"SUPPL-52","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19735s052,053lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2004","submission":"SUPPL-51","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19735slr051_floxin_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"FLOXIN","submission":"OFLOXACIN","actionType":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"FLOXIN","submission":"OFLOXACIN","actionType":"300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"FLOXIN","submission":"OFLOXACIN","actionType":"400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2011-02-25
)
)