FDA Approval for ENTADFI issued to VERU INC
$VERU
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 215423
Company: VERU INC
Company: VERU INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ENTADFI | FINASTERIDE;TADALAFIL | 5MG;5MG | CAPSULE;ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 12/09/2021 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215423s000lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/09/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215423s000lbl.pdf |