Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215338
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
06/23/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
VANCOMYCIN HYDROCHLORIDE
FOR SOLUTION;ORAL; EQ 250MG BASE/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | No | AA | 061667 | ANI PHARMS |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE/5ML | FOR SOLUTION;ORAL | Prescription | No | AA | 215338 | AMNEAL |