FDA Tentative Approval for TESTOSTERONE UNDECANOATE
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 208088
Company: LIPOCINE INC
Company: LIPOCINE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TESTOSTERONE UNDECANOATE | TESTOSTERONE UNDECANOATE | UNKNOWN | UNKNOWN | None (Tentative Approval) | None | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 12/08/2020 | ORIG-1 | Tentative Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208088Orig1s000TA_ltr.pdf |