Drugs@FDA: FDA Approved Drug Products

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG TABLET;ORAL-28 Prescription No AB 077182 MAYNE PHARMA
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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