Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INTRAVENOUS | 500MG/VIAL | 1 | DORIBAX | DORIPENEM |
| 002 | INJECTABLE;INTRAVENOUS | 250MG/VIAL | 1 | DORIBAX | DORIPENEM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2007-10-12 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2009-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2009-02-11 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2009-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2013-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2013-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2013-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2012-01-26 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2014-01-17 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2013-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2015-08-10 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2015-11-13 | STANDARD |
Submissions Property Types
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 0 |
CDER Filings
SHIONOGI INC
cder:Array
(
[0] => Array
(
[ApplNo] => 22106
[companyName] => SHIONOGI INC
[docInserts] => ["",""]
[products] => [{"drugName":"DORIBAX","activeIngredients":"DORIPENEM","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DORIBAX","activeIngredients":"DORIPENEM","strength":"250MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/10\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022106s015lbl.pdf\"}]","notes":"Please see"},{"actionDate":"01\/17\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022106s012lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022106s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022106s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2013","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022106s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022106s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2013","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022106s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2012","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022106s011lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2009","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022106s002s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2009","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022106s002s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2009","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022106s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022106lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DORIBAX","submission":"DORIPENEM","actionType":"500MG\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DORIBAX","submission":"DORIPENEM","actionType":"250MG\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2015-08-10
)
)