ANDA 075231

NEXGEN PHARMA INC

FDA Drug Application

Application #075231

Documents

• Letter: 2003-04-10

Application Sponsors

ANDA 075231

NEXGEN PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

325MG;50MG;40MG;30MG

0

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	2001-11-30
LABELING; Labeling	SUPPL	2	AP	2002-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-08-20
LABELING; Labeling	SUPPL	6	AP	2015-11-20	STANDARD
REMS; REMS	SUPPL	8	AP	2018-09-18

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	7
SUPPL	8	Null	7

TE Codes

001

Prescription

AB

CDER Filings

LGM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75231
            [companyName] => LGM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE","activeIngredients":"ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","strength":"325MG;50MG;40MG;30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE","submission":"ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","actionType":"325MG;50MG;40MG;30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)