Application Sponsors
| ANDA 064125 | ACS DOBFAR SPA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 750MG BASE/VIAL | 0 | CEFUROXIME SODIUM | CEFUROXIME SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 1.5GM BASE/VIAL | 0 | CEFUROXIME SODIUM | CEFUROXIME SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1997-05-30 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2004-08-23 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2007-01-31 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2012-11-21 | |
| LABELING; Labeling | SUPPL | 9 | AP | 2016-04-12 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2021-10-08 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 13 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AP |
CDER Filings
ACS DOBFAR SPA
cder:Array
(
[0] => Array
(
[ApplNo] => 64125
[companyName] => ACS DOBFAR SPA
[docInserts] => ["",""]
[products] => [{"drugName":"CEFUROXIME SODIUM","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 750MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFUROXIME SODIUM","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 1.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CEFUROXIME SODIUM","submission":"CEFUROXIME SODIUM","actionType":"EQ 750MG BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFUROXIME SODIUM","submission":"CEFUROXIME SODIUM","actionType":"EQ 1.5GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)