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 3 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack85740bf6-7e88-4a6e-9ec9-3455e3b95e592026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackea5914ab-28f3-4cb3-bade-6eaccac214e42026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackbce7adf8-b4b5-4d7f-bf0d-ae1277ae3a2b2026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEQPharma, Inc.4992698e-5d5a-6468-e063-6394a90ab4042026-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.b19ec628-4034-4316-ad3d-46c1ee2207282026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.806b3e38-3b2a-4aaa-973c-e2d921bb353e2026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.c4312b7b-7a42-45f1-b6e6-e20ea76020c42026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.e2d5a2d5-5e55-426c-bc8d-d29729eba7752026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAvKARE7f224c88-9425-9ef0-01bc-dcf3bdafbd892026-01-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.9fda0f8d-b24e-4581-9dca-7aaaf86e24132026-01-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxineVENLAFAXINE HYDROCHLORIDENorthwind Health Company, LLCf2b5c729-17c8-7ecc-e053-2a95a90a2e532026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxineVENLAFAXINE HYDROCHLORIDENorthwind Health Company, LLCfb076577-b9da-c78b-e053-6394a90a107b2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENorthwind Health Company, LLCf757cac4-efa7-668c-e053-6294a90a720d2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEChartwell RX, LLC85ec2d3f-49e4-4ac5-bd4a-c227589dbf582025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: venlafaxine hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEQPharma, Inc.9e745ad7-be4f-4369-be23-587e1154e4ab2025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions0a1b6bcd-8d46-44ab-bc5d-65515601d2ff2025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEWestminster Pharmaceuticals, LLC349308ef-2caf-4fec-b428-56ae06c6771d2025-11-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEMajor Pharmaceuticalsd962f5af-7642-4c6e-b7be-3e089fe488732025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.22980b32-cbae-4f37-9fc0-b47221b2c32e2025-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.b18d726e-cdb2-4c80-a49d-330cddee17e92025-10-02Boxed 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.