Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 5MG | 0 | AMPHETAMINE SULFATE | AMPHETAMINE SULFATE |
| 002 | TABLET;ORAL | 10MG | 0 | AMPHETAMINE SULFATE | AMPHETAMINE SULFATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-09-26 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2022-02-10 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2022-02-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
AMNEAL PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 211139
[companyName] => AMNEAL PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/211139Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-09-26
)
)