Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077182
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG TABLET;ORAL-28 Prescription AB No No
DESOGESTREL; ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.125MG/0.025MG TABLET; ORAL-28 Prescription None No No
DESOGESTREL; ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG/0.025MG TABLET; ORAL-28 Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/24/2006 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2019 SUPPL-14 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

08/02/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

03/19/2009 SUPPL-4 Labeling

Label is not available on this site.

DESOGESTREL AND ETHINYL ESTRADIOL

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

DESOGESTREL; ETHINYL ESTRADIOL

There are no Therapeutic Equivalents.

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