ANDA 200739

NATCO PHARMA LTD

FDA Drug Application

Application #200739

Application Sponsors

ANDA 200739

NATCO PHARMA LTD

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

N/A; Not Applicable

ORIG

1

AP

2015-04-15

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

NATCO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200739
            [companyName] => NATCO PHARMA LTD
            [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":"04\/15\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-04-15
        )

)