Application Sponsors
| NDA 050459 | GLAXOSMITHKLINE | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | CAPSULE;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | AMOXIL | AMOXICILLIN |
| 002 | CAPSULE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | AMOXIL | AMOXICILLIN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1974-01-18 | PRIORITY |
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 50459
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["",""]
[products] => [{"drugName":"AMOXIL","activeIngredients":"AMOXICILLIN","strength":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"AMOXIL","activeIngredients":"AMOXICILLIN","strength":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMOXIL","submission":"AMOXICILLIN","actionType":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"AMOXIL","submission":"AMOXICILLIN","actionType":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)