ANDA 211364

LEADING PHARMA LLC

FDA Drug Application

Application #211364

Application Sponsors

ANDA 211364

LEADING PHARMA LLC

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

2020-02-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

LEADING PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211364
            [companyName] => LEADING PHARMA LLC
            [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":"02\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-07
        )

)