Application Sponsors
ANDA 062273 | GLAXOSMITHKLINE | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | TABLET;ORAL | EQ 250MG BASE | 0 | BEEPEN-VK | PENICILLIN V POTASSIUM |
002 | TABLET;ORAL | EQ 500MG BASE | 0 | BEEPEN-VK | PENICILLIN V POTASSIUM |
FDA Submissions
| ORIG | 1 | AP | 1980-08-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1989-02-06 | |
LABELING; Labeling | SUPPL | 5 | AP | 1996-03-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-04-20 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 62273
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["",""]
[products] => [{"drugName":"BEEPEN-VK","activeIngredients":"PENICILLIN V POTASSIUM","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BEEPEN-VK","activeIngredients":"PENICILLIN V POTASSIUM","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BEEPEN-VK","submission":"PENICILLIN V POTASSIUM","actionType":"EQ 250MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BEEPEN-VK","submission":"PENICILLIN V POTASSIUM","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)