ANDA 203594

WATSON LABS INC

FDA Drug Application

Application #203594

Documents

• Letter: 2016-10-14
• Label: 2016-10-27

Application Sponsors

ANDA 203594

WATSON LABS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

3MG,N/A;0.03MG,N/A;0.451MG,0.451MG

0

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-10-11
LABELING; Labeling	SUPPL	5	AP	2017-09-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	15

TE Codes

001

Prescription

AB

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203594
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM","strength":"3MG,N\/A;0.03MG,N\/A;0.451MG,0.451MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/11\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203594Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/11\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203594Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203594Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/29\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Proprietary Name Change","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-09-29
        )

)