U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204213
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FYAVOLV ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG TABLET;ORAL Prescription AB No No
FYAVOLV ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG 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
12/10/2015 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
05/06/2021 SUPPL-6 Labeling-Container/Carton Labels

Label is not available on this site.

FYAVOLV

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
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
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG TABLET;ORAL Prescription No AB 203038 GLENMARK GENERICS

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
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
Back to Top