BLA 017692

ORGANON USA INC

FDA Drug Application

Application #017692

Documents

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

Application Sponsors

BLA 017692

ORGANON USA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10,000 UNITS/VIAL

0

PREGNYL

GONADOTROPIN, CHORIONIC

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1976-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-12-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-11-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1991-01-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1992-06-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-02-21	STANDARD
LABELING; Labeling	SUPPL	12	AP	1999-11-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1999-04-02	STANDARD
LABELING; Labeling	SUPPL	18	AP	2007-02-07	STANDARD
LABELING; Labeling	SUPPL	20	AP	2007-12-03	STANDARD
LABELING; Labeling	SUPPL	21	AP	2011-04-15	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2013-02-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2014-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2015-01-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2015-10-02	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	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	21	Null	31
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0

CDER Filings

ORGANON USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17692
            [companyName] => ORGANON USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREGNYL","activeIngredients":"GONADOTROPIN, CHORIONIC","strength":"10,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/15\/2011","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/017692s021lbl.pdf\"}]","notes":""},{"actionDate":"02\/07\/2007","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/017692s018lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PREGNYL","submission":"GONADOTROPIN, CHORIONIC","actionType":"10,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2011-04-15
        )

)