ANDA 089007

MAYNE PHARMA INC

FDA Drug Application

Application #089007

Application Sponsors

ANDA 089007

MAYNE PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

325MG;50MG;40MG

0

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

FDA Submissions

	ORIG	1	AP	1986-03-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1988-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1988-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1987-06-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1992-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1988-03-29
LABELING; Labeling	SUPPL	14	AP	1988-09-20
LABELING; Labeling	SUPPL	15	AP	1988-10-26
LABELING; Labeling	SUPPL	16	AP	1988-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1988-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1988-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1989-04-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1990-12-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1990-12-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1990-12-31
LABELING; Labeling	SUPPL	23	AP	1990-12-31
LABELING; Labeling	SUPPL	24	AP	1991-12-03
LABELING; Labeling	SUPPL	26	AP	1993-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1995-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1995-09-15
LABELING; Labeling	SUPPL	29	AP	1996-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1998-04-06
LABELING; Labeling	SUPPL	31	AP	2001-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1998-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1998-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1998-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1998-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2001-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2002-08-13
LABELING; Labeling	SUPPL	38	AP	2003-05-08
LABELING; Labeling	SUPPL	43	AP	2011-06-22
LABELING; Labeling	SUPPL	44	AP	2013-10-18	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	43	Null	7
SUPPL	44	Null	15

TE Codes

001

Prescription

AA

CDER Filings

MAYNE PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89007
            [companyName] => MAYNE PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","strength":"325MG;50MG;40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","submission":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","actionType":"325MG;50MG;40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)