Application Sponsors
ANDA 205063 | ACTAVIS LABS FL | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Prescription | 006 |
Application Products
001 | CAPSULE;ORAL | 10MG | 0 | ISOTRETINOIN | ISOTRETINOIN |
002 | CAPSULE;ORAL | 20MG | 0 | ISOTRETINOIN | ISOTRETINOIN |
003 | CAPSULE;ORAL | 25MG | 0 | ISOTRETINOIN | ISOTRETINOIN |
004 | CAPSULE;ORAL | 30MG | 0 | ISOTRETINOIN | ISOTRETINOIN |
005 | CAPSULE;ORAL | 35MG | 0 | ISOTRETINOIN | ISOTRETINOIN |
006 | CAPSULE;ORAL | 40MG | 0 | ISOTRETINOIN | ISOTRETINOIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-03-31 | STANDARD |
REMS; REMS | SUPPL | 4 | AP | 2022-10-06 | |
Submissions Property Types
TE Codes
001 | Prescription | AB2 |
002 | Prescription | AB2 |
003 | Prescription | AB2 |
004 | Prescription | AB2 |
005 | Prescription | AB2 |
006 | Prescription | AB2 |
CDER Filings
ACTAVIS LABS FL
cder:Array
(
[0] => Array
(
[ApplNo] => 205063
[companyName] => ACTAVIS LABS FL
[docInserts] => ["",""]
[products] => [{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"35MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/31\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-03-31
)
)