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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021065
Company: APIL

Products on NDA 021065

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	Discontinued	None	Yes	No
FEMHRT	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.005MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021065

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
05/18/2023	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021065s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021065Orig1s025,s026ltr.pdf
05/18/2023	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021065s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021065Orig1s025,s026ltr.pdf
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.

Labels for NDA 021065

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/18/2023	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021065s025s026lbl.pdf
05/18/2023	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021065s025s026lbl.pdf
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

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