Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;ORAL | 10GM/15ML | 0 | LACTULOSE | LACTULOSE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-06-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2021-09-08 | UNKNOWN |
Submissions Property Types
TE Codes
CDER Filings
TORRENT
cder:Array
(
[0] => Array
(
[ApplNo] => 207786
[companyName] => TORRENT
[docInserts] => ["",""]
[products] => [{"drugName":"LACTULOSE","activeIngredients":"LACTULOSE","strength":"10GM\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-06-11
)
)