ANDA 077681

MAYNE PHARMA

FDA Drug Application

Application #077681

Documents

• Label: 2014-03-20
• Other: 2014-03-20

Application Sponsors

ANDA 077681

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.02MG;0.1MG

0

LEVONORGESTREL AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

	ORIG	1	AP	2006-05-31
LABELING; Labeling	SUPPL	12	AP	2017-09-14	STANDARD
LABELING; Labeling	SUPPL	15	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	12	Null	7
SUPPL	15	Null	7

TE Codes

001

Prescription

AB2

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77681
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.02MG;0.1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/31\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/077681Orig1s000Lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LEVONORGESTREL AND ETHINYL ESTRADIOL","submission":"ETHINYL ESTRADIOL; LEVONORGESTREL","actionType":"0.02MG;0.1MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2006-05-31
        )

)