Application Sponsors
| ANDA 061392 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | CAPSULE;ORAL | EQ 250MG BASE | 0 | PRINCIPEN | AMPICILLIN/AMPICILLIN TRIHYDRATE |
| 002 | CAPSULE;ORAL | EQ 500MG BASE | 0 | PRINCIPEN | AMPICILLIN/AMPICILLIN TRIHYDRATE |
FDA Submissions
| ORIG | 1 | AP | 1971-03-03 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1997-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2002-02-20 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 61392
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"PRINCIPEN","activeIngredients":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","strength":"EQ 250MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRINCIPEN","activeIngredients":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","strength":"EQ 500MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PRINCIPEN","submission":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","actionType":"EQ 250MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRINCIPEN","submission":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","actionType":"EQ 500MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)