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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021490
Company: APIL

Products on NDA 021490

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FEMCON FE	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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 021490

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2003	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021490lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21490ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-490_NorethinOvcon.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2017	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021490s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021490Orig1s019ltr.pdf
07/08/2016	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
12/22/2015	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
09/03/2015	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
01/05/2015	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
08/06/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/01/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/22/2016	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021490s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021490Orig1s010ltr.pdf
01/09/2008	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021490s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021490s007ltr.pdf
01/29/2007	SUPPL-5	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021490s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021490s005ltr.pdf

Labels for NDA 021490

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2017	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021490s019lbl.pdf
09/22/2016	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021490s010lbl.pdf
01/09/2008	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021490s007lbl.pdf
01/29/2007	SUPPL-5	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021490s005lbl.pdf
11/14/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021490lbl.pdf

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