Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203435
Company: NOVAST LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LERIBANE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG TABLET;ORAL Prescription AB No No
LERIBANE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG TABLET;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
06/03/2016 ORIG-1 Approval

Label is not available on this site.

LERIBANE

TABLET;ORAL; 0.005MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FYAVOLV ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG TABLET;ORAL Prescription No AB 204213 LUPIN LTD
LERIBANE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG TABLET;ORAL Prescription No AB 203435 NOVAST LABS LTD
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG TABLET;ORAL Prescription No AB 076221 BARR LABS INC
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG TABLET;ORAL Prescription No AB 203038 GLENMARK GENERICS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG TABLET;ORAL Prescription No AB 207259 MYLAN LABS LTD

TABLET;ORAL; 0.0025MG;0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FEMHRT ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG TABLET;ORAL Prescription No AB 021065 APIL
FYAVOLV ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG TABLET;ORAL Prescription No AB 204213 LUPIN LTD
LERIBANE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG TABLET;ORAL Prescription No AB 203435 NOVAST LABS LTD
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG TABLET;ORAL Prescription No AB 203038 GLENMARK GENERICS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG TABLET;ORAL Prescription No AB 207260 MYLAN LABS LTD

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