Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021367
Company: MILLICENT MFG PR
Company: MILLICENT MFG PR
| 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 |
| 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-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 | |
| 08/18/2023 | SUPPL-20 | Labeling-Package Insert | 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 |