Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 25MG | 0 | CLOZAPINE | CLOZAPINE |
| 002 | TABLET;ORAL | 100MG | 0 | CLOZAPINE | CLOZAPINE |
| 003 | TABLET;ORAL | 50MG | 0 | CLOZAPINE | CLOZAPINE |
| 004 | TABLET;ORAL | 200MG | 0 | CLOZAPINE | CLOZAPINE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2015-09-17 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2017-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2017-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2017-05-10 | STANDARD |
| REMS; REMS | SUPPL | 6 | AP | 2019-01-16 | |
| REMS; REMS | SUPPL | 10 | AP | 2021-02-18 | |
| REMS; REMS | SUPPL | 13 | AP | 2021-07-29 | |
| REMS; REMS | SUPPL | 14 | AP | 2021-11-10 | |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
MAYNE PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 203807
[companyName] => MAYNE PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/17\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"01\/16\/2019","submission":"SUPPL-6","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/10\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/10\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/10\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/10\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-01-16
)
)