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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021090
Company: ASPEN GLOBAL INC

Products on NDA 021090

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYCLESSA	DESOGESTREL; ETHINYL ESTRADIOL	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET;ORAL-28	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021090

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-090_Cyclessa.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021090s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021090Orig1s009ltr.pdf
08/09/2017	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021090s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021090Orig1s008ltr.pdf
09/10/2015	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/26/2007	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021090s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021090s004LTR.pdf
02/24/2004	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21090slr003ltr.pdf
03/08/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
06/27/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021090

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021090s009lbl.pdf
04/29/2022	SUPPL-9	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021090s009lbl.pdf
08/09/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021090s008lbl.pdf
08/09/2017	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021090s008lbl.pdf
03/26/2007	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021090s004lbl.pdf

Therapeutic Equivalents for NDA 021090

CYCLESSA

TABLET;ORAL-28; 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLESSA	DESOGESTREL; ETHINYL ESTRADIOL	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET;ORAL-28	Prescription	Yes	AB	021090	ASPEN GLOBAL INC
VELIVET	DESOGESTREL; ETHINYL ESTRADIOL	0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET;ORAL-28	Prescription	No	AB	076455	DURAMED PHARMS BARR

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