ANDA 202846

INVAGEN PHARMS

FDA Drug Application

Application #202846

Application Sponsors

ANDA 202846

INVAGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

37.5MG

0

PHENTERMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-02-05
LABELING; Labeling	SUPPL	2	AP	2017-05-31	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AA

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202846
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"37.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/05\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/31\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-05-31
        )

)