ANDA 213842

ALEMBIC PHARMS LTD

FDA Drug Application

Application #213842

Application Sponsors

ANDA 213842

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	67MG	0	FENOFIBRATE (MICRONIZED)	FENOFIBRATE
002	CAPSULE;ORAL	134MG	0	FENOFIBRATE (MICRONIZED)	FENOFIBRATE
003	CAPSULE;ORAL	200MG	0	FENOFIBRATE (MICRONIZED)	FENOFIBRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-10-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213842
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"67MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"134MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-19
        )

)