Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208212
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription AB No No
VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 40MG TABLET;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
09/30/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

VILAZODONE HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VIIBRYD VILAZODONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 022567 ALLERGAN
VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208212 TEVA PHARMS USA

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VIIBRYD VILAZODONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription Yes AB 022567 ALLERGAN
VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208212 TEVA PHARMS USA

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VIIBRYD VILAZODONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription Yes AB 022567 ALLERGAN
VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 208212 TEVA PHARMS USA

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