Application Sponsors
| ANDA 062727 | GLAXOSMITHKLINE | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 0 | TOTACILLIN-N | AMPICILLIN SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | 0 | TOTACILLIN-N | AMPICILLIN SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1986-12-19 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1994-07-29 | |
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 62727
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["",""]
[products] => [{"drugName":"TOTACILLIN-N","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOTACILLIN-N","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TOTACILLIN-N","submission":"AMPICILLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TOTACILLIN-N","submission":"AMPICILLIN SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)