Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211962
Company: XELLIA PHARMS APS
Company: XELLIA PHARMS APS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 2GM BASE/400ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) | SOLUTION;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 |
---|---|---|---|---|---|---|---|
02/15/2019 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211962s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211962Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211962Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/29/2021 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211962s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211962Orig1s011ltr.pdf | |
05/28/2021 | SUPPL-9 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211962s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211962Orig1s009ltr.pdf | |
09/03/2020 | SUPPL-3 | Labeling-Proprietary Name Change |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211962s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211962Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/28/2021 | SUPPL-9 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211962s009lbl.pdf | |
01/29/2021 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211962s011lbl.pdf | |
09/03/2020 | SUPPL-3 | Labeling-Proprietary Name Change | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211962s003lbl.pdf | |
02/15/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211962s000lbl.pdf |