FDA Approval for IMVEXXY issued to THERAPEUTICSMD INC
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 208564
Company: THERAPEUTICSMD INC
Company: THERAPEUTICSMD INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMVEXXY | ESTRADIOL | 0.004MG | INSERT;VAGINAL | Prescription | None | Yes | No |
| IMVEXXY | ESTRADIOL | 0.01MG | INSERT;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 |
|---|---|---|---|---|---|---|---|
| 05/29/2018 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208564s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208564Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208564Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/21/2019 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208564s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208564Orig1s003ltr.pdf | |
| 11/16/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/21/2019 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208564s003lbl.pdf | |
| 05/29/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208564s000lbl.pdf |