Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | POWDER;INTRAVENOUS | 400MG/VIAL | 1 | TEFLARO | CEFTAROLINE FOSAMIL |
| 002 | POWDER;INTRAVENOUS | 600MG/VIAL | 1 | TEFLARO | CEFTAROLINE FOSAMIL |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2010-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2011-03-11 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2012-05-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2012-05-03 | N/A |
| LABELING; Labeling | SUPPL | 8 | AP | 2012-10-23 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2013-05-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2013-07-29 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2013-12-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2014-02-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2015-08-31 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2015-08-31 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2015-08-31 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2016-05-27 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2016-05-27 | PRIORITY Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| EFFICACY; Efficacy | SUPPL | 22 | AP | 2019-09-13 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2020-11-27 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2021-12-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 22 | Null | 7 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 28 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
ALLERGAN
cder:Array
(
[0] => Array
(
[ApplNo] => 200327
[companyName] => ALLERGAN
[docInserts] => ["",""]
[products] => [{"drugName":"TEFLARO","activeIngredients":"CEFTAROLINE FOSAMIL","strength":"400MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"TEFLARO","activeIngredients":"CEFTAROLINE FOSAMIL","strength":"600MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"09\/13\/2019","submission":"SUPPL-22","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200327s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/27\/2016","submission":"SUPPL-17","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/200327s016s017lbl.pdf\"}]","notes":"Please see"},{"actionDate":"05\/27\/2016","submission":"SUPPL-16","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/200327s016s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200327s015lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2015","submission":"SUPPL-14","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200327s013s014s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2013","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200327s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2013","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200327Orig1s010lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"05\/29\/2013","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200327s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200327s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2012","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200327s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2011","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200327s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2011","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200327s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200327s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/29\/2010","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200327s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/200327s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/200327Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/200327Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"09\/13\/2019","submission":"SUPPL-22","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200327s022lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/200327Orig1s022ltr.pdf\"}]","notes":">"},{"actionDate":"05\/27\/2016","submission":"SUPPL-17","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/200327s016s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/200327Orig1s016,s017ltr.pdf\"}]","notes":"> Please see www.fda.gov\/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs."},{"actionDate":"05\/27\/2016","submission":"SUPPL-16","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/200327s016s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/200327Orig1s016,s017ltr.pdf\"}]","notes":">"},{"actionDate":"08\/31\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200327s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/200327Orig1s013,200327Orig1s014,200327Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"08\/31\/2015","submission":"SUPPL-14","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200327s013s014s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/200327Orig1s013,200327Orig1s014,200327Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"08\/31\/2015","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/200327Orig1s013,200327Orig1s014,200327Orig1s015ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/28\/2014","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2013","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200327s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200327Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"07\/29\/2013","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200327Orig1s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200327Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"05\/29\/2013","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200327s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200327Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"10\/23\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200327s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200327Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"05\/03\/2012","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200327s007lbl.pdf\"}]","notes":">"},{"actionDate":"05\/22\/2012","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200327s005ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/11\/2011","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200327s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/200327s003ltr.pdf\"}]","notes":">"},{"actionDate":"06\/29\/2011","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200327s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/200327s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-09-13
)
)