Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213927
Company: DEXCEL PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET, EXTENDED RELEASE;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
01/21/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

VENLAFAXINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 214127 ALKEM LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 214419 ASCENT PHARMS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211323 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213927 DEXCEL PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022104 OSMOTICA PHARM
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091272 SUN PHARM

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