Application Sponsors
| ANDA 062270 | GLAXOSMITHKLINE | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | FOR SOLUTION;ORAL | EQ 125MG BASE/5ML | 0 | BEEPEN-VK | PENICILLIN V POTASSIUM |
| 002 | FOR SOLUTION;ORAL | EQ 250MG BASE/5ML | 0 | BEEPEN-VK | PENICILLIN V POTASSIUM |
FDA Submissions
| ORIG | 1 | AP | 1980-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1989-02-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1991-02-22 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1995-05-08 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1996-03-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-04-20 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 62270
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["",""]
[products] => [{"drugName":"BEEPEN-VK","activeIngredients":"PENICILLIN V POTASSIUM","strength":"EQ 125MG BASE\/5ML","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BEEPEN-VK","activeIngredients":"PENICILLIN V POTASSIUM","strength":"EQ 250MG BASE\/5ML","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BEEPEN-VK","submission":"PENICILLIN V POTASSIUM","actionType":"EQ 125MG BASE\/5ML","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BEEPEN-VK","submission":"PENICILLIN V POTASSIUM","actionType":"EQ 250MG BASE\/5ML","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)