ANDA 201781

PRINSTON INC

FDA Drug Application

Application #201781

Application Sponsors

ANDA 201781

PRINSTON INC

Marketing Status

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

Application Products

001	CAPSULE;ORAL	7.5MG	0	TEMAZEPAM	TEMAZEPAM
002	CAPSULE;ORAL	15MG	0	TEMAZEPAM	TEMAZEPAM
003	CAPSULE;ORAL	22.5MG	0	TEMAZEPAM	TEMAZEPAM
004	CAPSULE;ORAL	30MG	0	TEMAZEPAM	TEMAZEPAM

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2015-06-04

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201781
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEMAZEPAM","activeIngredients":"TEMAZEPAM","strength":"7.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMAZEPAM","activeIngredients":"TEMAZEPAM","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMAZEPAM","activeIngredients":"TEMAZEPAM","strength":"22.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMAZEPAM","activeIngredients":"TEMAZEPAM","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/04\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-06-04
        )

)