BLA 020582

ORGANON USA INC

FDA Drug Application

Application #020582

Documents

• Letter: 2020-03-23
• Label: 2020-03-23
• Letter: 2020-03-23
• Letter: 2020-03-23
• Review: 2020-03-23
• Letter: 2020-03-23
• Review: 2020-03-23
• Review: 2020-03-23
• Other: 2020-03-23

Application Sponsors

BLA 020582

ORGANON USA INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	75 IU/VIAL	0	FOLLISTIM	FOLLITROPIN ALFA/BETA
002	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	150 IU/VIAL	0	FOLLISTIM	FOLLITROPIN ALFA/BETA

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1997-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-03-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-03-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-05-25	STANDARD
EFFICACY; Efficacy	SUPPL	6	TA	2002-02-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-07-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-07-10	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

ORGANON USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20582
            [companyName] => ORGANON USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOLLISTIM","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"75 IU\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FOLLISTIM","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"150 IU\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/26\/2002","submission":"SUPPL-6","supplementCategories":"Tentative Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20582s006lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FOLLISTIM","submission":"FOLLITROPIN ALFA\/BETA","actionType":"75 IU\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FOLLISTIM","submission":"FOLLITROPIN ALFA\/BETA","actionType":"150 IU\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2002-02-26
        )

)