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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076783
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARANELLE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,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
09/29/2004 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
04/29/2022 SUPPL-16 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

07/06/2020 SUPPL-11 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

ARANELLE

TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARANELLE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET;ORAL-28 Prescription No AB 076783 BARR
TRI-NORINYL 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET;ORAL-28 Prescription Yes AB 018977 MAYNE PHARMA
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