ANDA 207139

ACTAVIS LABS FL INC

FDA Drug Application

Application #207139

Documents

• Letter: 2017-06-22
• Label: 2017-06-27

Application Sponsors

ANDA 207139

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

EQ 7.5MG BASE

0

PAROXETINE MESYLATE

PAROXETINE MESYLATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-06-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	2023-01-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

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(
    [0] => Array
        (
            [ApplNo] => 207139
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PAROXETINE MESYLATE","activeIngredients":"PAROXETINE MESYLATE","strength":"EQ 7.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/20\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207139Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207139Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207139Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2017-06-20
        )

)