ANDA 207507

BRECKENRIDGE

FDA Drug Application

Application #207507

Application Sponsors

ANDA 207507

BRECKENRIDGE

Marketing Status

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

Application Products

001	TABLET;ORAL	0.25MG	0	ALPRAZOLAM	ALPRAZOLAM
002	TABLET;ORAL	0.5MG	0	ALPRAZOLAM	ALPRAZOLAM
003	TABLET;ORAL	1MG	0	ALPRAZOLAM	ALPRAZOLAM
004	TABLET;ORAL	2MG	0	ALPRAZOLAM	ALPRAZOLAM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-07-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207507
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALPRAZOLAM","activeIngredients":"ALPRAZOLAM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-09
        )

)