Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206616
Company: HIKMA PHARMS
Company: HIKMA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG 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 |
---|---|---|---|---|---|---|---|
10/03/2018 | 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 |
---|---|---|---|---|---|
05/25/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
08/20/2020 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
VANCOMYCIN HYDROCHLORIDE
INJECTABLE;INJECTION; 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 | INJECTABLE;INJECTION | Prescription | No | AP | 062663 | FRESENIUS KABI USA |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206616 | HIKMA PHARMS |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062912 | HOSPIRA |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062933 | HOSPIRA |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215195 | MEITHEAL |