ANDA 213857

LAURUS

FDA Drug Application

Application #213857

Application Sponsors

ANDA 213857

LAURUS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	100MG;25MG	0	LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR
002	TABLET;ORAL	200MG;50MG	0	LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-03-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LAURUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213857
            [companyName] => LAURUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPINAVIR AND RITONAVIR","activeIngredients":"LOPINAVIR; RITONAVIR","strength":"100MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOPINAVIR AND RITONAVIR","activeIngredients":"LOPINAVIR; RITONAVIR","strength":"200MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-21
        )

)