ANDA 078706

UPSHER SMITH LABS

FDA Drug Application

Application #078706

Documents

• Letter: 2008-06-10
• Other Important Information from FDA: 2008-07-01

Application Sponsors

ANDA 078706

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CAPSULE;ORAL	5MG	0	ZALEPLON	ZALEPLON
002	CAPSULE;ORAL	10MG	0	ZALEPLON	ZALEPLON

FDA Submissions

	ORIG	1	AP	2008-06-06
LABELING; Labeling	SUPPL	2	AP	2008-09-03
LABELING; Labeling	SUPPL	4	AP	2014-03-26	STANDARD

Submissions Property Types

SUPPL

4

Null

15

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78706
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZALEPLON","activeIngredients":"ZALEPLON","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZALEPLON","activeIngredients":"ZALEPLON","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZALEPLON","submission":"ZALEPLON","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZALEPLON","submission":"ZALEPLON","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)