ANDA 216332

LAURUS

FDA Drug Application

Application #216332

Application Sponsors

ANDA 216332

LAURUS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 600MG BASE;300MG

0

ABACAVIR SULFATE AND LAMIVUDINE

ABACAVIR SULFATE; LAMIVUDINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-07-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

LAURUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216332
            [companyName] => LAURUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR SULFATE AND LAMIVUDINE","activeIngredients":"ABACAVIR SULFATE; LAMIVUDINE","strength":"EQ 600MG BASE;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-25
        )

)