ANDA 040885

NEXGEN PHARMA

FDA Drug Application

Application #040885

Documents

• Review: 2020-03-24

Application Sponsors

ANDA 040885

NEXGEN PHARMA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

300MG;50MG;40MG

0

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

FDA Submissions

	ORIG	1	AP	2009-11-16
LABELING; Labeling	SUPPL	2	AP	2014-04-30	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AA

CDER Filings

NEXGEN PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40885
            [companyName] => NEXGEN PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","strength":"300MG;50MG;40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","submission":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","actionType":"300MG;50MG;40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)