Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076105
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRI-LEGEST FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG 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
10/26/2007 ORIG-1 Approval

Label is not available on this site.

TRI-LEGEST FE

TABLET;ORAL-28; 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTROSTEP FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET;ORAL-28 Prescription Yes AB 020130 APIL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET;ORAL-28 Prescription No AB 076629 MAYNE PHARMA
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET;ORAL-28 Prescription No AB 205069 MYLAN LABS LTD
TRI-LEGEST FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET;ORAL-28 Prescription No AB 076105 BARR

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