ANDA 208127

CROSSMEDIKA SA

FDA Drug Application

Application #208127

Application Sponsors

ANDA 208127

CROSSMEDIKA SA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	EQ 25MG BASE	0	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE
002	CAPSULE;ORAL	EQ 50MG BASE	0	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE
003	CAPSULE;ORAL	EQ 100MG BASE	0	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-04-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

CROSSMEDIKA SA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208127
            [companyName] => CROSSMEDIKA SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIMIPRAMINE MALEATE","activeIngredients":"TRIMIPRAMINE MALEATE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRIMIPRAMINE MALEATE","activeIngredients":"TRIMIPRAMINE MALEATE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"TRIMIPRAMINE MALEATE","activeIngredients":"TRIMIPRAMINE MALEATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-04-15
        )

)