Orange Book product · Brand (NDA)
EFFEXOR
VENLAFAXINE HYDROCHLORIDE
At a glance
Dec 28, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 28, 1993
32 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
VENLAFAXINE HYDROCHLORIDE
Strength
EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020151
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2008VENLAFAXINE HYDROCHLORIDEBrand (NDA)
NDA 022104 · OSMOTICA PHARM US
- 1997EFFEXOR XRBrand (NDA)
NDA 020699 · UPJOHN
- 2025VENLAFAXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217841 · ABON PHARMS LLC
- 2025VENLAFAXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218180 · TORRENT
- 2024VENLAFAXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217767 · ALEMBIC
- 2023VENLAFAXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217390 · GRANULES
- 2023VENLAFAXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214691 · AJANTA PHARMA LTD
- 2023VENLAFAXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 200430 · NOSTRUM PHARMS LLC
- 2022VENLAFAXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216044 · UNIQUE
- 2022VENLAFAXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215622 · ZYDUS PHARMS
- 2022VENLAFAXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214423 · PHARMADAX
- 2021VENLAFAXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214654 · YICHANG HUMANWELL
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

