BLA 020328

ORGANON USA INC

FDA Drug Application

Application #020328

Documents

• Other: 2020-03-22

Application Sponsors

BLA 020328

ORGANON USA INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	75 IU/VIAL;75 IU/VIAL	0	HUMEGON	MENOTROPINS (FSH;LH)
002	INJECTABLE;INJECTION	150 IU/VIAL;150 IU/VIAL	0	HUMEGON	MENOTROPINS (FSH;LH)

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1994-09-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-04-02	STANDARD
LABELING; Labeling	SUPPL	4	AP	1999-11-23	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0

CDER Filings

ORGANON USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20328
            [companyName] => ORGANON USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HUMEGON","activeIngredients":"MENOTROPINS (FSH;LH)","strength":"75 IU\/VIAL;75 IU\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HUMEGON","activeIngredients":"MENOTROPINS (FSH;LH)","strength":"150 IU\/VIAL;150 IU\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HUMEGON","submission":"MENOTROPINS (FSH;LH)","actionType":"75 IU\/VIAL;75 IU\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HUMEGON","submission":"MENOTROPINS (FSH;LH)","actionType":"150 IU\/VIAL;150 IU\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)