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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022501
Company: APIL

Summary Review

Products on NDA 022501

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LO LOESTRIN FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.01MG,0.01MG;1MG,N/A	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022501

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/2010	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022501s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022501s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022501_lo_loestrin_fe_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022501Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-15	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022501s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022501Orig1s015ltr.pdf
10/15/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022501s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022501Orig1s012ltr.pdf
10/10/2017	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022501Orig1s009ltr.pdf
08/09/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022501Orig1s008ltr.pdf
05/08/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/01/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022501

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-15	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022501s015lbl.pdf
04/29/2022	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022501s015lbl.pdf
10/15/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022501s012lbl.pdf
10/10/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s009lbl.pdf
08/09/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s008lbl.pdf
10/21/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022501s000lbl.pdf

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