Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076455
Company: DURAMED PHARMS BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESOGESTREL; ETHINYL DESOGESTREL; ETHINYL ESTRADIOL 0.125MG/0.025MG Tablet; Oral Prescription None No No
DESOGESTREL; ETHINYL DESOGESTREL; ETHINYL ESTRADIOL 0.15MG/0.025MG Tablet; Oral Prescription None No No
VELIVET DESOGESTREL; ETHINYL ESTRADIOL 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG TABLET;ORAL-28 Prescription AB 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
02/24/2004 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
07/14/2011 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

DESOGESTREL; ETHINYL

There are no Therapeutic Equivalents.

VELIVET

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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