ANDA 206287

LUPIN ATLANTIS

FDA Drug Application

Application #206287

Documents

• Letter: 2016-05-26

Application Sponsors

ANDA 206287

LUPIN ATLANTIS

Marketing Status

• Prescription: 001

Application Products

001

TABLET, CHEWABLE;ORAL

0.02MG;1MG

0

MIBELAS 24 FE

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-05-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-09-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2019-09-09	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	15
SUPPL	8	Null	15

TE Codes

001

Prescription

AB

CDER Filings

LUPIN ATLANTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206287
            [companyName] => LUPIN ATLANTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIBELAS 24 FE","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.02MG;1MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/24\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206287Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/09\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/09\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/09\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-09
        )

)