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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076380
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JUNEL 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 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
05/30/2003 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
08/18/2021 SUPPL-17 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

10/20/2004 SUPPL-4 Labeling

Label is not available on this site.

JUNEL 1/20

TABLET;ORAL-21; 0.02MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AUROVELA 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription No AB 207506 AUROBINDO PHARMA LTD
JUNEL 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription No AB 076380 BARR
LARIN 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription No AB 202995 NOVAST LABS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription No AB 206969 GLENMARK PHARMS LTD
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-21 Prescription No AB 202771 MYLAN LABS LTD
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