ANDA 087804

SPECGX LLC

FDA Drug Application

Application #087804

Application Sponsors

ANDA 087804

SPECGX LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

325MG;50MG;40MG

0

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

FDA Submissions

	ORIG	1	AP	1985-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-09-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-06-20
LABELING; Labeling	SUPPL	9	AP	1988-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1992-09-03
LABELING; Labeling	SUPPL	11	AP	1988-08-24
LABELING; Labeling	SUPPL	12	AP	1989-11-21
LABELING; Labeling	SUPPL	16	AP	1992-07-16
LABELING; Labeling	SUPPL	18	AP	1993-05-27
LABELING; Labeling	SUPPL	19	AP	1994-03-16
LABELING; Labeling	SUPPL	20	AP	1994-06-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1994-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1998-11-23
LABELING; Labeling	SUPPL	25	AP	1998-11-23
LABELING; Labeling	SUPPL	26	AP	1998-08-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2000-07-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2002-08-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2002-08-26
LABELING; Labeling	SUPPL	30	AP	2002-10-21
LABELING; Labeling	SUPPL	34	AP	2006-10-10
LABELING; Labeling	SUPPL	38	AP	2012-01-20
LABELING; Labeling	SUPPL	39	AP	2013-10-18	STANDARD

Submissions Property Types

SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	21	Null	0
SUPPL	24	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	38	Null	7
SUPPL	39	Null	15

TE Codes

001

Prescription

AA

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87804
            [companyName] => SPECGX LLC
            [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
        )

)