Documents
Application Sponsors
| ANDA 203039 | TEVA PHARMS USA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, ORALLY DISINTEGRATING;ORAL | 150MG | 0 | CLOZAPINE | CLOZAPINE |
| 002 | TABLET, ORALLY DISINTEGRATING;ORAL | 200MG | 0 | CLOZAPINE | CLOZAPINE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2015-11-25 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2021-04-16 | STANDARD |
| REMS; REMS | SUPPL | 5 | AP | 2019-01-16 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-04-16 | STANDARD |
| REMS; REMS | SUPPL | 9 | AP | 2021-02-18 | |
| REMS; REMS | SUPPL | 10 | AP | 2021-07-29 | |
| REMS; REMS | SUPPL | 12 | AP | 2021-11-10 | |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 12 | Null | 15 |
CDER Filings
TEVA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 203039
[companyName] => TEVA PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"150MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"200MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"11\/25\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203039Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/25\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203039Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203039Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"01\/16\/2019","submission":"SUPPL-5","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-01-16
)
)