Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022407
Company: THERAVANCE INC
Company: THERAVANCE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIBATIV | TELAVANCIN | 250MG | INJECTABLE; INJECTION | Prescription | None | No | No |
| VIBATIV | TELAVANCIN | 750MG | INJECTABLE; INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 06/21/2013 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022407s000,022110s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022407Orig1s000,022110Orig1s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022407_vibativ_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022407Orig1s000SumR.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/21/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022407s000,022110s003lbl.pdf |