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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021367
Company: MILLICENT

Products on NDA 021367

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FEMRING	ESTRADIOL ACETATE	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE;VAGINAL	Prescription	None	Yes	No
FEMRING	ESTRADIOL ACETATE	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE;VAGINAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021367

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/20/2003	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021367lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21367ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021367TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-21	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021367s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021367Orig1s021ltr.pdf
08/18/2023	SUPPL-20	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021367Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021367Orig1s020ltr.pdf
11/01/2017	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021367s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021367Orig1s016ltr.pdf
08/08/2017	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021367s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021367Orig1s014,021367Orig1s015ltr.pdf
08/08/2017	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021367s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021367Orig1s014,021367Orig1s015ltr.pdf
05/29/2014	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021367s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021367Orig1s013ltr.pdf
05/20/2009	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021367s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021367s009ltr.pdf
02/14/2007	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021367s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021367s007ltr.pdf
08/16/2005	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021367s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021367s005ltr.pdf
03/11/2005	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21367s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21367s002ltr.pdf

Labels for NDA 021367

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-21	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021367s021lbl.pdf
08/18/2023	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021367Orig1s020lbl.pdf
08/18/2023	SUPPL-20	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021367Orig1s020lbl.pdf
08/18/2023	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021367Orig1s020lbl.pdf
11/01/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021367s016lbl.pdf
08/08/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021367s014s015lbl.pdf
08/08/2017	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021367s014s015lbl.pdf
05/29/2014	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021367s013lbl.pdf
05/20/2009	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021367s009lbl.pdf
02/14/2007	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021367s007lbl.pdf
08/16/2005	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021367s005lbl.pdf
03/11/2005	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21367s002lbl.pdf
03/20/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021367lbl.pdf

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