Documents
Application Sponsors
| NDA 207131 | BAXTER HLTHCARE CORP | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | EQ 2GM BASE/100ML (EQ 20MG BASE/ML) | 0 | CEFAZOLIN IN PLASTIC CONTAINER | CEFAZOLIN SODIUM |
| 002 | SOLUTION;INTRAVENOUS | EQ 1GM BASE/50ML (EQ 20MG BASE/ML) | 1 | CEFAZOLIN IN PLASTIC CONTAINER | CEFAZOLIN SODIUM |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2015-08-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2016-08-01 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2016-10-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2021-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-09-20 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 8 | Null | 6 |
CDER Filings
BAXTER HLTHCARE CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 207131
[companyName] => BAXTER HLTHCARE CORP
[docInserts] => ["",""]
[products] => [{"drugName":"CEFAZOLIN IN PLASTIC CONTAINER","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 2GM BASE\/100ML (EQ 20MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"10\/11\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207131s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207131s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207131s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/07\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207131s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207131Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207131Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207131Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"10\/11\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207131s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207131Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"08\/01\/2016","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/25\/2016","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2016-10-11
)
)