ANDA 203478

NATCO PHARMA LTD

FDA Drug Application

Application #203478

Application Sponsors

ANDA 203478

NATCO PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 5MG BASE	0	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE
002	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 10MG BASE	0	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-07-01
LABELING; Labeling	SUPPL	2	AP	2020-09-04	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

NATCO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203478
            [companyName] => NATCO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 5MG BASE","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 10MG BASE","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/01\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-07-01
        )

)