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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213059
Company: KNACK

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None 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
02/15/2022 ORIG-1 Approval STANDARD

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