Application Sponsors
ANDA 212218 | JUBILANT CADISTA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | 25MG | 0 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE |
002 | CAPSULE;ORAL | 50MG | 0 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE |
003 | CAPSULE;ORAL | 75MG | 0 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-10-21 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
JUBILANT CADISTA
cder:Array
(
[0] => Array
(
[ApplNo] => 212218
[companyName] => JUBILANT CADISTA
[docInserts] => ["",""]
[products] => [{"drugName":"CLOMIPRAMINE HYDROCHLORIDE","activeIngredients":"CLOMIPRAMINE HYDROCHLORIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOMIPRAMINE HYDROCHLORIDE","activeIngredients":"CLOMIPRAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOMIPRAMINE HYDROCHLORIDE","activeIngredients":"CLOMIPRAMINE HYDROCHLORIDE","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/21\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-10-21
)
)