Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021065
Company: APIL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FEMHRT ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG TABLET;ORAL Prescription AB No No
FEMHRT ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
10/15/1999 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21065LBLA.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21065LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21065LBLPATIENT.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21065_Femhrt.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2017 SUPPL-24 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021065s024lbl.pdf
03/25/2014 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
07/15/2013 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
09/13/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
01/08/2014 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021065s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021065Orig1s020ltr.pdf
01/14/2005 SUPPL-12 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21065s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21065s012ltr.pdf
01/20/2004 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21065slr009_femhrt_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21065slr009ltr.pdf
12/19/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
09/14/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
07/14/2000 SUPPL-4 Labeling

Label is not available on this site.
04/20/2000 SUPPL-3 Labeling

Label is not available on this site.
07/03/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
03/07/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/01/2017 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021065s024lbl.pdf
01/08/2014 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021065s020lbl.pdf
01/14/2005 SUPPL-12 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21065s012lbl.pdf
01/20/2004 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21065slr009_femhrt_lbl.pdf
10/15/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21065LBLA.PDF

FEMHRT

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
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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