U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 211598
Company: HETERO LABS LTD V

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VORICONAZOLE VORICONAZOLE 200MG/5ML FOR SUSPENSION;ORAL Prescription AB 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
08/08/2025 ORIG-1 Approval STANDARD

Label is not available on this site.

VORICONAZOLE

FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VFEND VORICONAZOLE 200MG/5ML FOR SUSPENSION;ORAL Prescription Yes AB 021630 PF PRISM CV
VORICONAZOLE VORICONAZOLE 200MG/5ML FOR SUSPENSION;ORAL Prescription No AB 205034 AMNEAL PHARMS
VORICONAZOLE VORICONAZOLE 200MG/5ML FOR SUSPENSION;ORAL Prescription No AB 211598 HETERO LABS LTD V
VORICONAZOLE VORICONAZOLE 200MG/5ML FOR SUSPENSION;ORAL Prescription No AB 206799 NOVEL LABS INC
VORICONAZOLE VORICONAZOLE 200MG/5ML FOR SUSPENSION;ORAL Prescription No AB 216805 ZHEJIANG POLY PHARM
Back to Top