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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209193
Company: DEXCEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG 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
10/31/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2022 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

VENLAFAXINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; EQ 150MG 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 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 214127 ALKEM LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 214609 APPCO
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 214419 ASCENT PHARMS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211323 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209193 DEXCEL
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205468 NOSTRUM LABS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022104 OSMOTICA PHARM
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091272 SUN PHARM
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 215622 ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; EQ 225MG 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 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 214127 ALKEM LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 214609 APPCO
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 214419 ASCENT PHARMS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211323 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209193 DEXCEL
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 216044 JB CHEMS PHARMS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205468 NOSTRUM LABS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022104 OSMOTICA PHARM
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091272 SUN PHARM
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 215622 ZYDUS PHARMS
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