Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | 0 | CEFAZOLIN AND DEXTROSE | CEFAZOLIN SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 1 | CEFAZOLIN AND DEXTROSE | CEFAZOLIN SODIUM |
| 003 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | 1 | CEFAZOLIN AND DEXTROSE | CEFAZOLIN SODIUM |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2000-07-27 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2004-06-29 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2005-05-06 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2008-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2007-09-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2012-01-13 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2012-04-23 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2012-12-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2014-03-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2013-08-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2014-09-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 25 | AP | 2015-10-08 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| EFFICACY; Efficacy | SUPPL | 27 | AP | 2020-11-23 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2021-10-08 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 5 | Null | 9 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 15 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 27 | Null | 15 |
| SUPPL | 31 | Null | 15 |
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 50779
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"CEFAZOLIN AND DEXTROSE","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFAZOLIN AND DEXTROSE","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CEFAZOLIN AND DEXTROSE","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"10\/08\/2015","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050779s025lbl.pdf\"}]","notes":"Please see"},{"actionDate":"04\/23\/2012","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050779s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2012","submission":"SUPPL-18","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050779s018lb.pdf\"}]","notes":""},{"actionDate":"10\/31\/2008","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050779s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2007","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050779s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2004","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50779slr005_cefazolin_lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/50779lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CEFAZOLIN AND DEXTROSE","submission":"CEFAZOLIN SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFAZOLIN AND DEXTROSE","submission":"CEFAZOLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CEFAZOLIN AND DEXTROSE","submission":"CEFAZOLIN SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2015-10-08
)
)