ANDA 205811

ACTAVIS LABS FL INC

FDA Drug Application

Application #205811

Documents

• Letter: 2016-08-23
• Label: 2016-08-23

Application Sponsors

ANDA 205811

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

10MG;10MG

0

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-08-19	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-02-24	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205811
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE","activeIngredients":"DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE","strength":"10MG;10MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/19\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205811Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205811Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205811Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/24\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-24
        )

)