Application Sponsors
| ANDA 091048 | SAGENT PHARMS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 0 | CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | 0 | CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2017-01-04 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2017-08-15 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-05-21 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 4 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
SAGENT PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 91048
[companyName] => SAGENT PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CEFEPIME HYDROCHLORIDE","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFEPIME HYDROCHLORIDE","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CEFEPIME HYDROCHLORIDE","submission":"CEFEPIME HYDROCHLORIDE","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFEPIME HYDROCHLORIDE","submission":"CEFEPIME HYDROCHLORIDE","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)