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 7 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LP922388b3-fc1c-46c6-b314-9049bd042df72023-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Lifesciences Limited1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b2023-05-19Name fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions0aedeaf8-9b6c-4a44-a5fe-9d74516f542d2023-04-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackf02cc6e8-186f-46e8-9675-70fd55d002c42023-03-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: venlafaxine hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxineVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions5bd03cf1-e8fc-44f3-9c41-06515b897f3b2023-02-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions8d6e699b-24bf-4e77-8a7f-acd496a700c72023-01-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: venlafaxine hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEDr. Reddy's Laboratories Limited106d0d7b-925b-74e7-83cb-562144ce1f922022-12-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.5351fe67-17d9-42ec-9e8b-6585fdb9e29e2022-10-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: venlafaxine hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LPaaa14e95-904e-45c6-be4d-c94167b203002022-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LP18e77a42-6552-4042-9ed3-046c94f4f9212022-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDEVENLAFAXINEXLCare Pharmaceuticals, Inc.68f40801-d35e-464e-ac94-21016b617ea22021-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDEVENLAFAXINECamber Pharmaceuticals, Inc.8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32021-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12021-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: VENLAFAXINE HYDROCHLORIDE
generic name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEAnnora Pharma Private Limitede901e476-58bd-4204-baaa-a4634ae65ab32020-11-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: VENLAFAXINE HYDROCHLORIDE
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEDr.Reddy's Laboratories Ltd.7027be98-61d6-a986-c9df-60ceef5f7ff02018-12-06Boxed 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.