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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201584
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BLISOVI FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;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
11/18/2015 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2020 SUPPL-16 Labeling-Container/Carton Labels

Label is not available on this site.

09/26/2018 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/26/2018 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

BLISOVI FE 1/20

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AUROVELA FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 207505 AUROBINDO PHARMA LTD
BLISOVI FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 201584 LUPIN LTD
HAILEY FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 206597 GLENMARK PHARMS LTD
JUNEL FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 076081 BARR
LARIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 091454 NOVAST LABS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 202772 MYLAN LABS LTD
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