ANDA 209000

ALEMBIC PHARMS LTD

FDA Drug Application

Application #209000

Application Sponsors

ANDA 209000

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

5%

0

ACYCLOVIR

ACYCLOVIR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-04-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209000
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"5%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/06\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/12\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-12
        )

)