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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202996
Company: NOVAST LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LARIN 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG 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
03/20/2014 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
04/05/2024 SUPPL-10 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

04/05/2024 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

04/05/2024 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

LARIN 1.5/30

TABLET;ORAL-21; 0.03MG;1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AUROVELA 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 207581 AUROBINDO PHARMA
HAILEY 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 209297 GLENMARK SPECLT
JUNEL 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 076381 BARR
LARIN 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 202996 NOVAST LABS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 202770 XIROMED
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