ANDA 040864

NOVAST LABS

FDA Drug Application

Application #040864

Documents

• Other: 2018-05-01

Application Sponsors

ANDA 040864

NOVAST LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

325MG;50MG;40MG

0

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

FDA Submissions

	ORIG	1	AP	2008-12-01
LABELING; Labeling	SUPPL	2	AP	2014-06-16	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AA

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40864
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","strength":"325MG;50MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","submission":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","actionType":"325MG;50MG;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)