NDA 021443

ASPEN

FDA Drug Application

Application #021443

Documents

• Label: 2004-05-19
• Label: 2007-04-25
• Letter: 2004-05-26
• Letter: 2007-05-01
• Letter: 2007-05-01
• Letter: 2015-07-09
• Label: 2015-07-01
• Review: 2006-07-27
• Label: 2017-11-02
• Label: 2020-12-01
• Label: 2020-12-01
• Letter: 2020-12-02
• Letter: 2020-12-02

Application Sponsors

NDA 021443

ASPEN

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	TABLET;ORAL	0.3MG	0	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B
002	TABLET;ORAL	0.45MG	0	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B
003	TABLET;ORAL	0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B
004	TABLET;ORAL	1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B
005	TABLET;ORAL	0.9MG	0	ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2004-05-10	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2007-04-23	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2007-04-27	N/A
LABELING; Labeling	SUPPL	9	AP	2015-06-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	2017-11-01	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-11-30	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-11-30	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	9	Null	15
SUPPL	10	Null	6
SUPPL	11	Null	6
SUPPL	12	Null	7

CDER Filings

ASPEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21443
            [companyName] => ASPEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENJUVIA","activeIngredients":"ESTROGENS, CONJUGATED SYNTHETIC B","strength":"0.3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENJUVIA","activeIngredients":"ESTROGENS, CONJUGATED SYNTHETIC B","strength":"0.45MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENJUVIA","activeIngredients":"ESTROGENS, CONJUGATED SYNTHETIC B","strength":"0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENJUVIA","activeIngredients":"ESTROGENS, CONJUGATED SYNTHETIC B","strength":"1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENJUVIA","activeIngredients":"ESTROGENS, CONJUGATED SYNTHETIC B","strength":"0.9MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/30\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021443s011s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2020","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021443s011s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021443s010lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2015","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021443s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2007","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021443s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/021443lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ENJUVIA","submission":"ESTROGENS, CONJUGATED SYNTHETIC B","actionType":"0.3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENJUVIA","submission":"ESTROGENS, CONJUGATED SYNTHETIC B","actionType":"0.45MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENJUVIA","submission":"ESTROGENS, CONJUGATED SYNTHETIC B","actionType":"0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENJUVIA","submission":"ESTROGENS, CONJUGATED SYNTHETIC B","actionType":"1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENJUVIA","submission":"ESTROGENS, CONJUGATED SYNTHETIC B","actionType":"0.9MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2020-11-30
        )

)