NDA 009402

PAR STERILE PRODUCTS

FDA Drug Application

Application #009402

Documents

• Letter: 2003-12-16
• Letter: 2003-12-16
• Letter: 2004-07-28
• Letter: 2007-10-15
• Label: 2004-06-02
• Label: 2003-12-16
• Label: 2004-07-28
• Label: 2017-11-02
• Letter: 2017-11-06
• Letter: 2022-02-17
• Label: 2022-02-23

Application Sponsors

NDA 009402

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

002	INJECTABLE;INJECTION	10MG/ML	1	DELESTROGEN	ESTRADIOL VALERATE
003	INJECTABLE;INJECTION	40MG/ML	1	DELESTROGEN	ESTRADIOL VALERATE
004	INJECTABLE;INJECTION	20MG/ML	1	DELESTROGEN	ESTRADIOL VALERATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1954-07-15	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1982-09-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1983-07-18
LABELING; Labeling	SUPPL	21	AP	1984-03-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1985-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1984-06-01
LABELING; Labeling	SUPPL	24	AP	1984-11-16
LABELING; Labeling	SUPPL	25	AP	1984-11-26
LABELING; Labeling	SUPPL	26	AP	1985-01-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1986-05-05
LABELING; Labeling	SUPPL	29	AP	1989-03-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1987-09-11
LABELING; Labeling	SUPPL	31	AP	1987-12-28
LABELING; Labeling	SUPPL	33	AP	1989-03-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1989-05-05
LABELING; Labeling	SUPPL	35	AP	1990-01-12
LABELING; Labeling	SUPPL	36	AP	1998-06-17	STANDARD
LABELING; Labeling	SUPPL	37	AP	2003-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2002-07-17
LABELING; Labeling	SUPPL	39	AP	2003-12-12	STANDARD
LABELING; Labeling	SUPPL	40	AP	2004-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2007-10-11	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	2015-08-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2015-10-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	2016-03-10
LABELING; Labeling	SUPPL	52	AP	2017-11-01	STANDARD
LABELING; Labeling	SUPPL	60	AP	2022-02-16	STANDARD

Submissions Property Types

SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	27	Null	0
SUPPL	30	Null	0
SUPPL	34	Null	0
SUPPL	38	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	49	Null	0
SUPPL	52	Null	6
SUPPL	60	Null	15

TE Codes

002	Prescription	AO
003	Prescription	AO
004	Prescription	AO

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 9402
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DELESTROGEN","activeIngredients":"ESTRADIOL VALERATE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DELESTROGEN","activeIngredients":"ESTRADIOL VALERATE","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DELESTROGEN","activeIngredients":"ESTRADIOL VALERATE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/01\/2017","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/009402s052lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2004","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/09402s040lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2003","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/09402slr037_delestrogen_lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2003","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/09402slr037_delestrogen_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DELESTROGEN","submission":"ESTRADIOL VALERATE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DELESTROGEN","submission":"ESTRADIOL VALERATE","actionType":"40MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DELESTROGEN","submission":"ESTRADIOL VALERATE","actionType":"20MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-11-01
        )

)