NDA 018977

MAYNE PHARMA

FDA Drug Application

Application #018977

Documents

• Label: 2017-08-10
• Letter: 2017-08-15
• Label: 2022-05-02
• Letter: 2022-05-03

Application Sponsors

NDA 018977

MAYNE PHARMA

Marketing Status

• Discontinued: 001
• Prescription: 002

Application Products

001	TABLET;ORAL-21	0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG	0	TRI-NORINYL 21-DAY	ETHINYL ESTRADIOL; NORETHINDRONE
002	TABLET;ORAL-28	0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG	1	TRI-NORINYL 28-DAY	ETHINYL ESTRADIOL; NORETHINDRONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1984-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1984-11-13	STANDARD
LABELING; Labeling	SUPPL	6	AP	1985-04-16
LABELING; Labeling	SUPPL	7	AP	1985-10-25
LABELING; Labeling	SUPPL	8	AP	1986-07-17
LABELING; Labeling	SUPPL	10	AP	1989-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1989-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1989-02-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1989-10-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1989-10-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1990-09-19	STANDARD
LABELING; Labeling	SUPPL	16	AP	1990-09-27
LABELING; Labeling	SUPPL	17	AP	1994-02-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1992-07-31	STANDARD
LABELING; Labeling	SUPPL	19	AP	1995-08-30	STANDARD
LABELING; Labeling	SUPPL	20	AP	1994-12-13	STANDARD
LABELING; Labeling	SUPPL	21	AP	1994-12-13	STANDARD
LABELING; Labeling	SUPPL	22	AP	1996-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1997-07-30	STANDARD
LABELING; Labeling	SUPPL	24	AP	1999-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1999-02-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2000-02-14	STANDARD
LABELING; Labeling	SUPPL	27	AP	2000-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2001-08-15	STANDARD
LABELING; Labeling	SUPPL	41	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	43	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	18	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	41	Null	6
SUPPL	43	Null	6

TE Codes

002

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18977
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRI-NORINYL 21-DAY","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG","dosageForm":"TABLET;ORAL-21","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRI-NORINYL 28-DAY","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/018977s041lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRI-NORINYL 21-DAY","submission":"ETHINYL ESTRADIOL; NORETHINDRONE","actionType":"0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG","submissionClassification":"TABLET;ORAL-21","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRI-NORINYL 28-DAY","submission":"ETHINYL ESTRADIOL; NORETHINDRONE","actionType":"0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-08-09
        )

)