Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211962
Company: XELLIA PHARMS APS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/100ML (EQ 5MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/200ML (EQ 5MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 2GM BASE/400ML (EQ 5MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/150ML (EQ 5MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes No
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes No
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes 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
02/15/2019 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211962s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211962Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211962Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/15/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211962s000lbl.pdf

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