Application Sponsors
| ANDA 204375 | MACLEODS PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | CAPSULE;ORAL | EQ 20MG BASE | 0 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE |
| 002 | CAPSULE;ORAL | EQ 40MG BASE | 0 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE |
| 003 | CAPSULE;ORAL | EQ 60MG BASE | 0 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE |
| 004 | CAPSULE;ORAL | EQ 80MG BASE | 0 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-02-17 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-09-09 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-09-09 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2020-09-09 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 14 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 204375
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ZIPRASIDONE HYDROCHLORIDE","activeIngredients":"ZIPRASIDONE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZIPRASIDONE HYDROCHLORIDE","activeIngredients":"ZIPRASIDONE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZIPRASIDONE HYDROCHLORIDE","activeIngredients":"ZIPRASIDONE HYDROCHLORIDE","strength":"EQ 60MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZIPRASIDONE HYDROCHLORIDE","activeIngredients":"ZIPRASIDONE HYDROCHLORIDE","strength":"EQ 80MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/17\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/09\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/09\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/09\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-09-09
)
)