ANDA 075288

MAYNE PHARMA

FDA Drug Application

Application #075288

Documents

• Letter: 1999-07-28
• Label: 2003-12-23
• Review: 2003-12-23

Application Sponsors

ANDA 075288

MAYNE PHARMA

Marketing Status

• Discontinued: 001
• Prescription: 002

Application Products

001	TABLET;ORAL-21	0.03MG;0.3MG	0	LOW-OGESTREL-21	ETHINYL ESTRADIOL; NORGESTREL
002	TABLET;ORAL-28	0.03MG;0.3MG	0	LOW-OGESTREL-28	ETHINYL ESTRADIOL; NORGESTREL

FDA Submissions

	ORIG	1	AP	1999-07-28
LABELING; Labeling	SUPPL	8	AP	2005-06-24
LABELING; Labeling	SUPPL	21	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	23	AP	2022-02-28	STANDARD
LABELING; Labeling	SUPPL	24	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	21	Null	15
SUPPL	23	Null	15
SUPPL	24	Null	15

TE Codes

002

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75288
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOW-OGESTREL-21","activeIngredients":"ETHINYL ESTRADIOL; NORGESTREL","strength":"0.03MG;0.3MG","dosageForm":"TABLET;ORAL-21","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LOW-OGESTREL-28","activeIngredients":"ETHINYL ESTRADIOL; NORGESTREL","strength":"0.03MG;0.3MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/28\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/99\\\/75288_Norgestrel%20And%20Ethinyl%20Estradiol_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LOW-OGESTREL-21","submission":"ETHINYL ESTRADIOL; NORGESTREL","actionType":"0.03MG;0.3MG","submissionClassification":"TABLET;ORAL-21","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LOW-OGESTREL-28","submission":"ETHINYL ESTRADIOL; NORGESTREL","actionType":"0.03MG;0.3MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1999-07-28
        )

)