Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 1GM BASE | 1 | CEFTAZIDIME IN DEXTROSE CONTAINER | CEFTAZIDIME |
| 002 | INJECTABLE;INJECTION | EQ 2GM BASE | 1 | CEFTAZIDIME IN DEXTROSE CONTAINER | CEFTAZIDIME |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2011-06-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2014-04-01 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2015-05-15 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-07-29 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2021-10-20 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 9 | Null | 7 |
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 50823
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"CEFTAZIDIME IN DEXTROSE CONTAINER","activeIngredients":"CEFTAZIDIME","strength":"EQ 1GM BASE","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"CEFTAZIDIME IN DEXTROSE CONTAINER","activeIngredients":"CEFTAZIDIME","strength":"EQ 2GM BASE","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/29\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050823s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050823s004lbl.pdf\"}]","notes":"Please see"}]
[originalApprovals] => [{"actionDate":"CEFTAZIDIME IN DEXTROSE CONTAINER","submission":"CEFTAZIDIME","actionType":"EQ 1GM BASE","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CEFTAZIDIME IN DEXTROSE CONTAINER","submission":"CEFTAZIDIME","actionType":"EQ 2GM BASE","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-07-29
)
)