Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021166
Company: ASCEND THERAPS US
Company: ASCEND THERAPS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESTROGEL | ESTRADIOL | 0.06% | GEL;TOPICAL | Discontinued | None | No | No |
| ESTROGEL | ESTRADIOL | 0.06% (1.25GM/ACTIVATION) | GEL, METERED;TRANSDERMAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/19/2026 | SUPPL-20 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021166Orig1s020lbl.pdf | |
| 02/15/2024 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021166s019lbl.pdf | |
| 02/15/2024 | SUPPL-19 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021166s019lbl.pdf | |
| 08/01/2023 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021166s018lbl.pdf | |
| 08/01/2023 | SUPPL-18 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021166s018lbl.pdf | |
| 11/30/2021 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021166s017lbl.pdf | |
| 11/30/2021 | SUPPL-17 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021166s017lbl.pdf | |
| 11/01/2017 | SUPPL-15 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021166s015lbl.pdf | |
| 11/01/2017 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021166s015lbl.pdf | |
| 03/25/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021166s010lbl.pdf | |
| 01/25/2008 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021166s007lbl.pdf | |
| 07/25/2007 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021166s005lbl.pdf | |
| 02/09/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21166_estrogel_lbl.pdf |