Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 750MG BASE/VIAL | 1 | CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER | CEFUROXIME SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 1.5GM BASE/VIAL | 1 | CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER | CEFUROXIME SODIUM |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2001-02-21 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2003-08-18 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2004-06-29 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2005-05-06 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2007-09-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2013-12-12 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2015-05-01 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 20 | AP | 2020-12-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 6 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 50780
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 750MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 1.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/01\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050780s019lbl.pdf\"}]","notes":"Please see"},{"actionDate":"09\/10\/2007","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050780s011lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/50780_Cefuroxime_prntlbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER","submission":"CEFUROXIME SODIUM","actionType":"EQ 750MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER","submission":"CEFUROXIME SODIUM","actionType":"EQ 1.5GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2015-05-01
)
)