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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204654
Company: APIL

Summary Review

Products on NDA 204654

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LO MINASTRIN FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.01MG,0.01MG,N/A;1MG,N/A,N/A	TABLET, CHEWABLE, TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204654

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2013	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204654s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204654Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204654Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204654Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204654s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204654Orig1s008ltr.pdf
06/28/2017	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204654s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204654Orig1s006ltr.pdf
10/07/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/20/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/16/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204654

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204654s008lbl.pdf
06/28/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204654s006lbl.pdf
07/24/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204654s000lbl.pdf

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