ANDA 215077

ALEMBIC PHARMS LTD

FDA Drug Application

Application #215077

Application Sponsors

ANDA 215077

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAMUSCULAR

250MG/5ML (50MG/ML)

0

FULVESTRANT

FULVESTRANT

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AO

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215077
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FULVESTRANT","activeIngredients":"FULVESTRANT","strength":"250MG\/5ML (50MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FULVESTRANT","submission":"FULVESTRANT","actionType":"250MG\/5ML (50MG\/ML)","submissionClassification":"SOLUTION;INTRAMUSCULAR","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)