ANDA 076910

IMPAX LABS

FDA Drug Application

Application #076910

Documents

• Letter: 2005-04-28

Application Sponsors

ANDA 076910

IMPAX LABS

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

	ORIG	1	AP	2005-04-18
LABELING; Labeling	SUPPL	3	AP	2016-05-29	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76910
            [companyName] => IMPAX LABS
            [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":"ANAGRELIDE HYDROCHLORIDE","submission":"ANAGRELIDE HYDROCHLORIDE","actionType":"EQ 0.5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ANAGRELIDE HYDROCHLORIDE","submission":"ANAGRELIDE HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)