Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205694
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 01/21/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/06/2023 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/19/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/19/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
VANCOMYCIN HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 500MG 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 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216591 | ASPIRO |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205780 | EUGIA PHARMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062663 | FRESENIUS KABI USA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205694 | GLAND PHARMA LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212332 | HAINAN POLY PHARM |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062911 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062931 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215197 | MEITHEAL |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065397 | MYLAN LABS LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065401 | PHARM ASSOC |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204107 | XELLIA PHARMS APS |
INJECTABLE;INJECTION; EQ 1GM 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 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216591 | ASPIRO |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205780 | EUGIA PHARMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062663 | FRESENIUS KABI USA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205694 | GLAND PHARMA LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212332 | HAINAN POLY PHARM |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203300 | HIKMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062912 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062933 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215197 | MEITHEAL |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065397 | MYLAN LABS LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065401 | PHARM ASSOC |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204107 | XELLIA PHARMS APS |
INJECTABLE;INJECTION; EQ 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 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205779 | EUGIA PHARMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062663 | FRESENIUS KABI USA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205694 | GLAND PHARMA LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215821 | HAINAN POLY |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204360 | HIKMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 063076 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215196 | MEITHEAL |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065432 | MYLAN LABS LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200837 | SAGENT PHARMS |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201048 | SANDOZ INC |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204125 | XELLIA PHARMS APS |
INJECTABLE;INJECTION; EQ 10GM 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 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205779 | EUGIA PHARMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062663 | FRESENIUS KABI USA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205694 | GLAND PHARMA LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215821 | HAINAN POLY |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204360 | HIKMA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 063076 | HOSPIRA |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065455 | HOSPIRA INC |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215196 | MEITHEAL |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091554 | MYLAN LABS LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200837 | SAGENT PHARMS |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201048 | SANDOZ INC |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204125 | XELLIA PHARMS APS |