Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203371
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.025MG;0.8MG TABLET, CHEWABLE;ORAL 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
04/23/2014 ORIG-1 Approval

Label is not available on this site.

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

TABLET, CHEWABLE;ORAL; 0.025MG;0.8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KAITLIB FE ETHINYL ESTRADIOL; NORETHINDRONE 0.025MG;0.8MG TABLET, CHEWABLE;ORAL Prescription No AB 203448 LUPIN LTD
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.025MG;0.8MG TABLET, CHEWABLE;ORAL Prescription Yes AB 022573 APIL
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.025MG;0.8MG TABLET, CHEWABLE;ORAL Prescription No AB 203371 MYLAN LABS LTD

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