Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211109
Company: TETRAPHASE PHARMS
Company: TETRAPHASE PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XERAVA | ERAVACYCLINE DIHYDROCHLORIDE | EQ 50MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | None | Yes | Yes |
XERAVA | ERAVACYCLINE DIHYDROCHLORIDE | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
08/27/2018 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211109Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211109Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/13/2024 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211109s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211109Orig1s009ltr.pdf | |
06/03/2020 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211109Orig1s004ltr.pdf |
06/18/2019 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/13/2024 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211109s009lbl.pdf | |
08/27/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf |