BLA 021211

ORGANON USA INC

FDA Drug Application

Application #021211

Documents

• Letter: 2020-03-23
• Letter: 2020-03-23
• Label: 2020-03-23
• Letter: 2020-03-23
• Letter: 2020-03-23
• Label: 2020-03-23
• Label: 2020-03-23
• Label: 2020-03-23
• Review: 2020-03-23
• Other: 2020-03-25

Application Sponsors

BLA 021211

ORGANON USA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Discontinued: 003
• Prescription: 004

Application Products

001	INJECTABLE;SUBCUTANEOUS	300 IU/0.36ML	0	FOLLISTIM AQ	FOLLITROPIN ALFA/BETA
002	INJECTABLE;SUBCUTANEOUS	600 IU/0.72ML	0	FOLLISTIM AQ	FOLLITROPIN ALFA/BETA
003	INJECTABLE;SUBCUTANEOUS	150 IU/0.18ML	0	FOLLISTIM AQ	FOLLITROPIN ALFA/BETA
004	INJECTABLE;SUBCUTANEOUS	900 IU/1.08ML	0	FOLLISTIM AQ	FOLLITROPIN ALFA/BETA

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2004-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2005-02-11	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2010-06-28	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2011-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2015-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2016-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2016-12-15	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	7	Null	7
SUPPL	11	Null	15
SUPPL	16	Null	0

CDER Filings

ORGANON USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21211
            [companyName] => ORGANON USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOLLISTIM AQ","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"300 IU\/0.36ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"FOLLISTIM AQ","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"600 IU\/0.72ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"FOLLISTIM AQ","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"150 IU\/0.18ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FOLLISTIM AQ","activeIngredients":"FOLLITROPIN ALFA\/BETA","strength":"900 IU\/1.08ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/22\/2011","submission":"SUPPL-11","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021211s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2010","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021211s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2005","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/21211s002lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"03\/23\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21211_Follistim_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FOLLISTIM AQ","submission":"FOLLITROPIN ALFA\/BETA","actionType":"300 IU\/0.36ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FOLLISTIM AQ","submission":"FOLLITROPIN ALFA\/BETA","actionType":"600 IU\/0.72ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FOLLISTIM AQ","submission":"FOLLITROPIN ALFA\/BETA","actionType":"150 IU\/0.18ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FOLLISTIM AQ","submission":"FOLLITROPIN ALFA\/BETA","actionType":"900 IU\/1.08ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2011-08-22
        )

)