FDA Approval for XIPERE issued to CLEARSIDE BIOMEDICAL, INC
$CLSD
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 211950
Company: CLEARSIDE BIOMEDICAL, INC
Company: CLEARSIDE BIOMEDICAL, INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XIPERE | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE; SUSPENSION | 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 |
|---|---|---|---|---|---|---|---|
| 10/22/2021 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211950s000lbl.pdf httpS://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211950Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/22/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211950s000lbl.pdf | |
| 10/22/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211950s000lbl.pdf |