Application Sponsors
| NDA 050460 | GLAXOSMITHKLINE | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 005 |
| Discontinued | 006 |
Application Products
| 001 | FOR SUSPENSION;ORAL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | AMOXIL | AMOXICILLIN |
| 002 | FOR SUSPENSION;ORAL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | AMOXIL | AMOXICILLIN |
| 005 | FOR SUSPENSION;ORAL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | AMOXIL | AMOXICILLIN |
| 006 | FOR SUSPENSION;ORAL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LAROTID | AMOXICILLIN |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1974-01-18 | PRIORITY |
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 50460
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["",""]
[products] => [{"drugName":"AMOXIL","activeIngredients":"AMOXICILLIN","strength":"125MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"AMOXIL","activeIngredients":"AMOXICILLIN","strength":"250MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"AMOXIL","activeIngredients":"AMOXICILLIN","strength":"50MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"LAROTID","activeIngredients":"AMOXICILLIN","strength":"50MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMOXIL","submission":"AMOXICILLIN","actionType":"125MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"AMOXIL","submission":"AMOXICILLIN","actionType":"250MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"AMOXIL","submission":"AMOXICILLIN","actionType":"50MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"LAROTID","submission":"AMOXICILLIN","actionType":"50MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)