ANDA 076683

UPSHER SMITH LABS

FDA Drug Application

Application #076683

Documents

• Letter: 2005-04-28

Application Sponsors

ANDA 076683

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001
• Discontinued: 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	2010-08-31
LABELING; Labeling	SUPPL	4	AP	2012-11-13
LABELING; Labeling	SUPPL	5	AP	2012-11-13
LABELING; Labeling	SUPPL	6	AP	2015-06-01	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-06-01	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-12-31	STANDARD

Submissions Property Types

SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	15

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76683
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANAGRELIDE HYDROCHLORIDE","activeIngredients":"ANAGRELIDE HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ANAGRELIDE HYDROCHLORIDE","activeIngredients":"ANAGRELIDE HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ANAGRELIDE HYDROCHLORIDE","submission":"ANAGRELIDE HYDROCHLORIDE","actionType":"EQ 0.5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ANAGRELIDE HYDROCHLORIDE","submission":"ANAGRELIDE HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)