Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020323
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIVELLE | ESTRADIOL | 0.0375MG/24HR | SYSTEM;TRANSDERMAL | Discontinued | None | No | No |
| VIVELLE | ESTRADIOL | 0.05MG/24HR | SYSTEM;TRANSDERMAL | Discontinued | None | No | No |
| VIVELLE | ESTRADIOL | 0.075MG/24HR | SYSTEM;TRANSDERMAL | Discontinued | None | No | No |
| VIVELLE | ESTRADIOL | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Discontinued | None | No | No |
| VIVELLE | ESTRADIOL | 0.025MG/24HR | SYSTEM;TRANSDERMAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020323s038lbl.pdf | |
| 11/01/2017 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020323s036lbl.pdf | |
| 08/06/2004 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323s033lbl.pdf | |
| 01/22/2004 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf | |
| 01/22/2004 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf | |
| 01/22/2004 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf | |
| 08/16/2000 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf | |
| 02/25/2000 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S21LBL.PDF |