ANDA 207836

UNICHEM LABS LTD

FDA Drug Application

Application #207836

Application Sponsors

ANDA 207836

UNICHEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-03-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

UNICHEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207836
            [companyName] => UNICHEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/07\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/29\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-29
        )

)