Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214842
Company: EUGIA PHARMA SPECLTS
Company: EUGIA PHARMA SPECLTS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POSACONAZOLE | POSACONAZOLE | 300MG/16.7ML(18MG/ML) | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 05/23/2023 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214842Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214842Orig1s000TA_ltr.pdf |