Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE;ORAL | 100MG | 0 | CYCLOSPORINE | CYCLOSPORINE |
002 | CAPSULE;ORAL | 25MG | 0 | CYCLOSPORINE | CYCLOSPORINE |
FDA Submissions
| ORIG | 1 | AP | 2000-12-20 | |
LABELING; Labeling | SUPPL | 2 | AP | 2002-05-03 | |
LABELING; Labeling | SUPPL | 3 | AP | 2004-05-14 | |
LABELING; Labeling | SUPPL | 4 | AP | 2004-12-02 | |
LABELING; Labeling | SUPPL | 8 | AP | 2007-02-05 | |
LABELING; Labeling | SUPPL | 10 | AP | 2007-11-16 | |
LABELING; Labeling | SUPPL | 17 | AP | 2015-01-20 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB1 |
002 | Prescription | AB1 |
CDER Filings
MAYNE PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 65044
[companyName] => MAYNE PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CYCLOSPORINE","submission":"CYCLOSPORINE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CYCLOSPORINE","submission":"CYCLOSPORINE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)