FDA Approval for BIJUVA issued to THERAPEUTICSMD INC
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 210132
Company: THERAPEUTICSMD INC
Company: THERAPEUTICSMD INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BIJUVA | ESTRADIOL; PROGESTERONE | 1MG;100MG | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/28/2018 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210132s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210132Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210132Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/28/2021 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132Orig1s006lbl.pdf | |
| 06/22/2021 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210132Orig1s001, s003ltr.pdf | |
| 06/22/2021 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210132Orig1s001, s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/28/2021 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132Orig1s006lbl.pdf | |
| 06/22/2021 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf | |
| 06/22/2021 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf | |
| 10/28/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210132s000lbl.pdf |