FDA Approval for TESTOSTERONE UNDECANOATE issued to ANTARES PHARMA INC
$ATRS
Medical/Dental Instruments
Health Care
New Drug Application (NDA): 208088
Company: ANTARES PHARMA INC
Company: ANTARES PHARMA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TESTOSTERONE UNDECANOATE | TESTOSTERONE UNDECANOATE | UNKNOWN | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/28/2022 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208088s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208088Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/28/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208088s000lbl.pdf |