NDA 050536

MAYNE PHARMA

FDA Drug Application

Application #050536

Documents

• Letter: 2008-02-25
• Letter: 2013-03-22
• Label: 2008-02-25
• Letter: 2004-02-27
• Letter: 2003-12-22
• Letter: 2006-01-20
• Letter: 2012-02-21
• Label: 2006-01-13
• Label: 2013-03-26
• Label: 2012-02-17
• Label: 2018-04-24
• Letter: 2018-04-24

Application Sponsors

NDA 050536

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, DELAYED REL PELLETS;ORAL

250MG

1

ERYC

ERYTHROMYCIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1981-01-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1981-04-22	STANDARD
LABELING; Labeling	SUPPL	3	AP	1981-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1981-05-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1981-05-20	STANDARD
LABELING; Labeling	SUPPL	6	AP	1981-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-06-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1981-06-05	STANDARD
LABELING; Labeling	SUPPL	9	AP	1981-06-15
LABELING; Labeling	SUPPL	10	AP	1981-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1982-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-03-30	STANDARD
LABELING; Labeling	SUPPL	13	AP	2000-09-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-10-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1999-08-05	STANDARD
LABELING; Labeling	SUPPL	16	AP	2004-02-02	STANDARD
LABELING; Labeling	SUPPL	18	AP	2003-12-18	STANDARD
LABELING; Labeling	SUPPL	19	AP	2006-01-12	STANDARD
LABELING; Labeling	SUPPL	20	AP	2008-02-21	STANDARD
LABELING; Labeling	SUPPL	21	AP	2013-03-21	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	22	AP	2012-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2013-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2013-12-19	STANDARD
LABELING; Labeling	SUPPL	26	AP	2018-04-23	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	21	Null	7
SUPPL	22	Null	7
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50536
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERYC","activeIngredients":"ERYTHROMYCIN","strength":"250MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/23\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050536s026lbl.pdf\"}]","notes":""},{"actionDate":"03\/21\/2013","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050536s021lbl.pdf\"}]","notes":"Please see"},{"actionDate":"02\/14\/2012","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050536s022lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2008","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050536s020lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2006","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/050536s019lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ERYC","submission":"ERYTHROMYCIN","actionType":"250MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-04-23
        )

)