Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 211323
Company: CADILA PHARMS LTD
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
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
08/29/2019 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 211323 CADILA PHARMS LTD
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

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 211323 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209193 DEXCEL PHARMA
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

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 211323 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209193 DEXCEL PHARMA
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English