Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021367
Company: MILLICENT
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
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
11/01/2017 SUPPL-16 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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