Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213927
Company: DEXCEL PHARMA
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 | 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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