FDA.reportPublic FDA data

Application 078057

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE; ORAL37.5MGNoNo
002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE; ORAL75MGNoNo
003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE; ORAL150MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECoupler LLC5359012e-a868-3aa3-e063-6294a90a74e22026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDENorthStar RxLLCb865c175-e75d-4cb4-ac29-dec72226302c2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: VENLAFAXINE HYDROCHLORIDE
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEMacleods Pharmaceuticals Limited3e51f786-3691-4ec4-836b-7f2c9a385aa72026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAsclemed USA, Inc.c69d16fd-b82d-4708-aece-ab4f60b29cc62026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack7aa3edba-4248-49bb-86f7-06fdbf2a6fb72026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepacke2fa1bb0-ab86-4499-84cb-ff5e02a169912026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.1775b8bf-cd4f-4a8a-abd1-78d90de54fdd2026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEGranules Pharmaceuticals Inc.67059969-e291-4609-b130-0faacf2a19f02026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2a7d760c-fd9f-8026-e063-6294a90aaa432026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions7852be9e-0c1d-47a8-9513-c3a04b3657632026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions28c8f404-1dbd-4140-8959-32624d7c77242026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions296d6ab7-8c0c-40e5-8cb2-9d125b42b8bb2026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions33068acd-d361-4cd9-b994-02a7865ff04f2026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions812ca864-8230-4c84-a7f4-d1b926dee31a2026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions569e10d1-6432-473c-a026-ac438bd77bcd2026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.c0fa9a3b-692e-2c2e-e053-2995a90aa83a2026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEEpic Pharma, LLC430777f0-347c-4f21-8c5d-55f4e9897e742026-02-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.ddb51556-0292-4aa9-b781-a402c912591f2026-02-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackd7d1319c-500e-4ca0-83a1-a739cfa01cf72026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECoupler LLC4a007068-89d9-c296-e063-6394a90ad6d02026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.