Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209481
Company: MYLAN LABS LTD
Company: MYLAN LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;INTRAVENOUS | Discontinued | None | Yes | No |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | None | Yes | Yes |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER;INTRAVENOUS | Prescription | AP | Yes | Yes |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/VIAL | POWDER;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
07/10/2018 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209481s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209481Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209481Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/04/2022 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209481s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209481Orig1s016ltr.pdf | |
01/29/2021 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209481s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209481Orig1s012ltr.pdf | |
08/09/2019 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209481s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209481Orig1s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/04/2022 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209481s016lbl.pdf | |
01/29/2021 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209481s012lbl.pdf | |
08/09/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209481s005lbl.pdf | |
07/10/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209481s000lbl.pdf |
VANCOMYCIN HYDROCHLORIDE
POWDER;INTRAVENOUS; EQ 1.25GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 217401 | EUGIA PHARMA |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 217489 | HIKMA |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 209481 | MYLAN LABS LTD |
POWDER;INTRAVENOUS; EQ 1.5GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 217401 | EUGIA PHARMA |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 217489 | HIKMA |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 209481 | MYLAN LABS LTD |