Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 1 | CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER | CEFOXITIN SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | 1 | CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER | CEFOXITIN SODIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2006-03-10 | UNKNOWN |
| LABELING; Labeling | SUPPL | 2 | AP | 2010-02-04 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2008-01-07 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2010-02-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2012-12-12 | |
| LABELING; Labeling | SUPPL | 13 | AP | 2013-06-05 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 16 | AP | 2019-07-29 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 16 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 65214
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/29\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/065214s016lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2013","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/065214s013lbl.pdf\"}]","notes":"Please see"},{"actionDate":"02\/22\/2010","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/065214s008lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2010","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/065214s002lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER","submission":"CEFOXITIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER","submission":"CEFOXITIN SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-07-29
)
)