NDA 018679

MAYNE PHARMA

FDA Drug Application

Application #018679

Documents

• Label: 2015-10-14
• Label: 2016-06-17
• Letter: 2016-06-15

Application Sponsors

NDA 018679

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

100MG

1

TRIMETHOPRIM

TRIMETHOPRIM

FDA Submissions

	ORIG	1	AP	1982-07-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1985-06-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1986-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1986-10-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1987-11-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1987-11-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1993-03-01
LABELING; Labeling	SUPPL	17	AP	1989-03-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1994-10-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1995-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1995-02-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1996-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1997-04-16
LABELING; Labeling	SUPPL	25	AP	1997-03-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2000-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2002-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2002-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2002-05-15
LABELING; Labeling	SUPPL	31	AP	2002-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2002-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2002-05-15
LABELING; Labeling	SUPPL	34	AP	2003-06-18
LABELING; Labeling	SUPPL	38	AP	2008-02-11
LABELING; Labeling	SUPPL	40	AP	2012-07-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2016-08-11	STANDARD
LABELING; Labeling	SUPPL	44	AP	2016-06-13	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	40	Null	15
SUPPL	44	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18679
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIMETHOPRIM","activeIngredients":"TRIMETHOPRIM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/13\/2016","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018679s044lbl.pdf\"}]","notes":"Please see"},{"actionDate":"07\/12\/2012","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/018679s040lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRIMETHOPRIM","submission":"TRIMETHOPRIM","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-06-13
        )

)