Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 250MG | 1 | LEVAQUIN | LEVOFLOXACIN |
| 002 | TABLET;ORAL | 500MG | 1 | LEVAQUIN | LEVOFLOXACIN |
| 003 | TABLET;ORAL | 750MG | 1 | LEVAQUIN | LEVOFLOXACIN |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1996-12-20 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1998-05-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1998-03-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 1998-12-17 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1999-07-29 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1999-07-29 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1999-07-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2000-02-02 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2000-02-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1999-09-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-02-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-09-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2000-09-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-08-28 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2001-12-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-12-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2000-09-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-01-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2001-02-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2001-06-08 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2001-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2001-12-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2002-01-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2002-04-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 2002-10-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2002-06-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 27 | AP | 2003-05-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 28 | AP | 2003-10-23 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2004-03-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 30 | AP | 2004-07-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 33 | AP | 2004-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2004-09-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 35 | AP | 2004-11-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 36 | AP | 2004-11-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 37 | AP | 2005-08-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 39 | AP | 2006-01-20 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2006-06-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 41 | AP | 2007-09-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 42 | AP | 2007-05-31 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 43 | AP | 2007-09-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 44 | AP | 2007-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2007-06-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 47 | AP | 2008-05-05 | UNKNOWN |
| LABELING; Labeling | SUPPL | 48 | AP | 2007-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2007-11-16 | STANDARD |
| LABELING; Labeling | SUPPL | 50 | AP | 2007-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2008-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2008-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2009-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2009-03-12 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2011-02-25 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 59 | AP | 2011-06-09 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 61 | AP | 2012-04-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 62 | AP | 2011-10-11 | UNKNOWN |
| REMS; REMS | SUPPL | 64 | AP | 2011-10-11 | N/A |
| LABELING; Labeling | SUPPL | 65 | AP | 2013-08-14 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 66 | AP | 2014-05-23 | STANDARD |
| LABELING; Labeling | SUPPL | 67 | AP | 2016-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 68 | AP | 2017-02-08 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 69 | AP | 2018-07-02 | STANDARD |
| LABELING; Labeling | SUPPL | 70 | AP | 2018-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 71 | AP | 2019-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 72 | AP | 2019-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 73 | AP | 2020-06-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 10 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 35 | Null | 41 |
| SUPPL | 43 | Null | 26 |
| SUPPL | 53 | Null | 7 |
| SUPPL | 58 | Null | 6 |
| SUPPL | 59 | Null | 6 |
| SUPPL | 61 | Null | 21 |
| SUPPL | 62 | Null | 6 |
| SUPPL | 64 | Null | 6 |
| SUPPL | 65 | Null | 6 |
| SUPPL | 66 | Null | 6 |
| SUPPL | 67 | Null | 7 |
| SUPPL | 68 | Null | 7 |
| SUPPL | 69 | Null | 15 |
| SUPPL | 70 | Null | 15 |
| SUPPL | 71 | Null | 6 |
| SUPPL | 72 | Null | 7 |
| SUPPL | 73 | Null | 7 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 20634
[companyName] => JANSSEN PHARMS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/020634s073lbl.pdf#page=54"]
[products] => [{"drugName":"LEVAQUIN","activeIngredients":"LEVOFLOXACIN","strength":"250MG **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":"LEVAQUIN","activeIngredients":"LEVOFLOXACIN","strength":"500MG **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":"LEVAQUIN","activeIngredients":"LEVOFLOXACIN","strength":"750MG **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":"06\/22\/2020","submission":"SUPPL-73","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020634s073lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2019","submission":"SUPPL-71","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020634s071lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2019","submission":"SUPPL-72","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020634s072lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2018","submission":"SUPPL-70","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020634s070lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2018","submission":"SUPPL-69","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020634s069lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2017","submission":"SUPPL-68","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020634s068,020635s074,021721s035lbl.pdf\"}]","notes":"Please see"},{"actionDate":"07\/26\/2016","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020634s067,020635s073,021721s034lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2014","submission":"SUPPL-66","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020634s066,020635s072,021721s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2013","submission":"SUPPL-65","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020634s065,020635s071,021721s032lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2012","submission":"SUPPL-61","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020634s061,020635s067,021721s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2011","submission":"SUPPL-64","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020634s062s064,020635s068s070,021721s029s031lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2011","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020634s062s064,020635s068s070,021721s029s031lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2011","submission":"SUPPL-62","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020634s062s064,020635s068s070,021721s029s031lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2011","submission":"SUPPL-59","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020634s059,020635s065,021721s026lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2011","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020634s058,020635s064,021721s025lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2009","submission":"SUPPL-53","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"04\/27\/2009","submission":"SUPPL-53","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"10\/03\/2008","submission":"SUPPL-52","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021721s020_020635s57_020634s52_lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2008","submission":"SUPPL-51","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020634s051,020635s055,021721s019lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2007","submission":"SUPPL-50","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020634s050,020635s054,021721s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2007","submission":"SUPPL-49","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020634s049,020635s053,021721s017lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2007","submission":"SUPPL-48","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020634s048,020635s052,021721s016lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2007","submission":"SUPPL-41","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020634s041,020635s044,021721s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2007","submission":"SUPPL-43","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020634s043,020635s046,021721s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2007","submission":"SUPPL-45","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020634s045,020635s048,021721s031lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2007","submission":"SUPPL-42","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020634s042,020635s045,021721s010lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2007","submission":"SUPPL-44","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020634s044,020635s047,021721s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2006","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020634s040,020635s043,021721s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/20\/2006","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020634s039,020635s042,021721s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2005","submission":"SUPPL-37","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020634s037,020635s038,021721s002lbl.pdf\"}]","notes":""},{"actionDate":"11\/24\/2004","submission":"SUPPL-35","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20634s035,20635s035,21721s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2004","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20635s037,20634s036lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2004","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20634s033,034,20635s033,034lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2004","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20634s033,034,20635s033,034lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2004","submission":"SUPPL-30","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20634s030,20635s030lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2004","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20634slr029,20635slr029_levaquin_lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2003","submission":"SUPPL-27","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20634se1-027,20635se1-026_levaquin_lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2001","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20634s15s21s22lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2001","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20634s15s21s22lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2001","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20634s15s21s22lbl.pdf\"}]","notes":""},{"actionDate":"09\/08\/2000","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20634S13lbl.pdf\"}]","notes":""},{"actionDate":"09\/08\/2000","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20634S13lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/17\/1998","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/98\\\/020634s04_prntlbl_P1.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"LEVAQUIN","submission":"LEVOFLOXACIN","actionType":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"LEVAQUIN","submission":"LEVOFLOXACIN","actionType":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"LEVAQUIN","submission":"LEVOFLOXACIN","actionType":"750MG **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] => 2020-06-22
)
)