Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE;ORAL | 8MCG | 0 | LUBIPROSTONE | LUBIPROSTONE |
002 | CAPSULE;ORAL | 24MCG | 0 | LUBIPROSTONE | LUBIPROSTONE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-06-27 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
ANCHEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 201442
[companyName] => ANCHEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"LUBIPROSTONE","activeIngredients":"LUBIPROSTONE","strength":"8MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LUBIPROSTONE","activeIngredients":"LUBIPROSTONE","strength":"24MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-06-27
)
)