BLA 020580

ORGANON USA INC

FDA Drug Application

Application #020580

Documents

• Other: 2020-03-23

Application Sponsors

BLA 020580

ORGANON USA INC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

30,000USP UNITS;8,000USP UNITS;30,000USP UNITS

0

COTAZYM

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDA

ORIG

1

AP

1996-12-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ORGANON USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20580
            [companyName] => ORGANON USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"COTAZYM","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"30,000USP UNITS;8,000USP UNITS;30,000USP UNITS","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"COTAZYM","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"30,000USP UNITS;8,000USP UNITS;30,000USP UNITS","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)