ANDA 200243

LANNETT CO INC

FDA Drug Application

Application #200243

Application Sponsors

ANDA 200243

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

325MG;50MG;40MG

0

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-09-13
LABELING; Labeling	SUPPL	10	AP	2016-04-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	10	Null	7

TE Codes

001

Prescription

AA

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200243
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","strength":"325MG;50MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/13\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/15\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-04-15
        )

)