Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020655
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALORA | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| ALORA | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| ALORA | ESTRADIOL | 0.1MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| ALORA | ESTRADIOL | 0.025MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/05/2025 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020655s022lbl.pdf | |
| 02/15/2024 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020655s023lbl.pdf | |
| 03/30/2020 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020655Orig1s019lbl.pdf | |
| 11/01/2017 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020655s020lbl.pdf | |
| 05/19/2005 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020655s011lbl.pdf | |
| 11/18/2003 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20655slr006_alora_lbl.pdf | |
| 04/05/2002 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20655s8lbl.pdf |