Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203413
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLAFEM 0.5/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG 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
12/16/2015 ORIG-1 Approval

Label is not available on this site.

CYCLAFEM 0.5/35

TABLET;ORAL-28; 0.035MG;0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREVICON 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 017743 ALLERGAN
CYCLAFEM 0.5/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 203413 VINTAGE PHARMS
CYONANZ ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 207055 AUROBINDO PHARMA LTD
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 070686 MAYNE PHARMA
NORTREL 0.5/35-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 072695 BARR
WERA ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 091204 NOVAST LABS LTD

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