Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215324
Company: STERISCIENCE
Company: STERISCIENCE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | AP | No | No |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER;INTRAVENOUS | Prescription | AP | No | No |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/VIAL | POWDER;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 10/02/2025 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
VANCOMYCIN HYDROCHLORIDE
POWDER;INTRAVENOUS; EQ 750MG 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 750MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 218140 | GLAND |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 209481 | MYLAN LABS LTD |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 215324 | STERISCIENCE |
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 | 218140 | GLAND |
| 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 |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 215324 | STERISCIENCE |
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 | 218140 | GLAND |
| 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 |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 215324 | STERISCIENCE |