Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205034
Company: AMNEAL PHARMS
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
04/13/2016 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 206799 NOVEL LABS INC

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