Application Sponsors
| ANDA 207792 | AMNEAL PHARMS NY | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | CAPSULE;ORAL | 10MG | 0 | ISOTRETINOIN | ISOTRETINOIN |
| 002 | CAPSULE;ORAL | 20MG | 0 | ISOTRETINOIN | ISOTRETINOIN |
| 003 | CAPSULE;ORAL | 30MG | 0 | ISOTRETINOIN | ISOTRETINOIN |
| 004 | CAPSULE;ORAL | 40MG | 0 | ISOTRETINOIN | ISOTRETINOIN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-09-29 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2018-05-02 | STANDARD |
| REMS; REMS | SUPPL | 3 | AP | 2018-04-23 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2018-08-31 | STANDARD |
| REMS; REMS | SUPPL | 11 | AP | 2020-12-09 | |
| REMS; REMS | SUPPL | 14 | AP | 2021-10-08 | |
| LABELING; Labeling | SUPPL | 15 | AP | 2021-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2022-08-24 | STANDARD |
| REMS; REMS | SUPPL | 20 | AP | 2022-10-06 | |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
AMNEAL PHARMS NY
cder:Array
(
[0] => Array
(
[ApplNo] => 207792
[companyName] => AMNEAL PHARMS NY
[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":"30MG","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":"09\/29\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/09\/2020","submission":"SUPPL-11","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/31\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/23\/2018","submission":"SUPPL-3","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/02\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-12-09
)
)