NDA 021090

ASPEN GLOBAL INC

FDA Drug Application

Application #021090

Documents

• Letter: 2007-03-31
• Label: 2007-03-31
• Letter: 2004-02-25
• Review: 2004-05-06
• Label: 2017-08-10
• Letter: 2017-08-15
• Letter: 2022-05-03
• Label: 2022-05-09

Application Sponsors

NDA 021090

ASPEN GLOBAL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG

1

CYCLESSA

DESOGESTREL; ETHINYL ESTRADIOL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2000-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-03-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2004-02-24	STANDARD
LABELING; Labeling	SUPPL	4	AP	2007-03-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2015-09-10	STANDARD
LABELING; Labeling	SUPPL	8	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	15
SUPPL	9	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ASPEN GLOBAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21090
            [companyName] => ASPEN GLOBAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLESSA","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021090s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021090s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2007","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021090s004lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CYCLESSA","submission":"DESOGESTREL; ETHINYL ESTRADIOL","actionType":"0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-08-09
        )

)