Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 214460
Company: EMERGENT BIODEFENSE
Company: EMERGENT BIODEFENSE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TEMBEXA | BRINCIDOFOVIR | 10MG/ML | SUSPENSION;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/04/2021 | ORIG-1 | Approval | Type 2 - New Active Ingredient | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214460s000,214461s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214460Origs000,214461Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214460Orig1s000, 214461Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/03/2021 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214460s001,214461s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214460Orig1s001; 214461Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/03/2021 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214460s001,214461s001lbl.pdf | |
| 06/04/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214460s000,214461s000lbl.pdf |