ANDA 203146

MACLEODS PHARMS LTD

FDA Drug Application

Application #203146

Documents

• Letter: 2014-09-23

Application Sponsors

ANDA 203146

MACLEODS PHARMS 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	2014-09-19
LABELING; Labeling	SUPPL	17	AP	2019-11-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	17	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203146
            [companyName] => MACLEODS PHARMS 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":"09\/19\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203146Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/29\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-29
        )

)