Application Sponsors
| ANDA 213571 | UPSHER SMITH LABS | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 40MG | 0 | ISOTRETINOIN | ISOTRETINOIN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2021-04-12 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2022-08-24 | STANDARD |
| REMS; REMS | SUPPL | 6 | AP | 2022-10-06 | |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 6 | Null | 15 |
TE Codes
CDER Filings
UPSHER SMITH LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 213571
[companyName] => UPSHER SMITH LABS
[docInserts] => ["",""]
[products] => [{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-04-12
)
)