ANDA 207582

WATSON LABS INC

FDA Drug Application

Application #207582

Documents

• Letter: 2016-10-19

Application Sponsors

ANDA 207582

WATSON LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	2MG	0	PERPHENAZINE	PERPHENAZINE
002	TABLET;ORAL	4MG	0	PERPHENAZINE	PERPHENAZINE
003	TABLET;ORAL	8MG	0	PERPHENAZINE	PERPHENAZINE
004	TABLET;ORAL	16MG	0	PERPHENAZINE	PERPHENAZINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-10-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207582
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERPHENAZINE","activeIngredients":"PERPHENAZINE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PERPHENAZINE","activeIngredients":"PERPHENAZINE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PERPHENAZINE","activeIngredients":"PERPHENAZINE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PERPHENAZINE","activeIngredients":"PERPHENAZINE","strength":"16MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/17\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207582Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-10-17
        )

)