ANDA 209151

TORRENT

FDA Drug Application

Application #209151

Application Sponsors

ANDA 209151

TORRENT

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	EQ 0.5MG BASE	0	ANAGRELIDE HYDROCHLORIDE	ANAGRELIDE HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 1MG BASE	0	ANAGRELIDE HYDROCHLORIDE	ANAGRELIDE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-06-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209151
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANAGRELIDE HYDROCHLORIDE","activeIngredients":"ANAGRELIDE HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ANAGRELIDE HYDROCHLORIDE","activeIngredients":"ANAGRELIDE HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/30\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-06-30
        )

)