ANDA 215669

HETERO LABS LTD III

FDA Drug Application

Application #215669

Application Sponsors

ANDA 215669

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

200MG/5ML

0

ACYCLOVIR

ACYCLOVIR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-07-01

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215669
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"200MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/01\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-01
        )

)