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 4 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.6c1d0d4f-c8e2-4035-8f4e-7a46bfe3f0592025-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.b055df74-51f9-401f-8cca-24269a0163df2025-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.0c404290-2806-4756-bca3-2d639b4009632025-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.de6e30f8-c8ef-4016-b228-0f188645347b2025-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: venlafaxine hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.92b3f73d-d6ca-4d7d-9035-5700f527cb852025-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.653f3f95-98d0-4ce0-bf10-ac7938be690e2025-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.3cbe3e18-9a7e-aaa3-e063-6394a90abf922025-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEMarlex Pharmaceuticals, Inc.3c2e188f-76aa-a022-e063-6294a90abfc92025-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: VENLAFAXINE HYDROCHLORIDE
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDETrigen Laboratories, LLCfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c972025-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.5c943206-6df8-4fc5-ab1d-d34b9715182c2025-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: VENLAFAXINE HYDROCHLORIDE
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAmerican Health Packaginge05bdeb4-07a9-441e-901b-f2aea550db2b2025-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY35d3148b-52f3-197c-e063-6294a90a44e32025-05-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINERising Pharma Holdings, Inc.074f4478-e81b-45a2-ae85-ffd27bed940f2025-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEDr.Reddys Laboratories Incf5c21429-d5d0-9f93-a465-6e5e0e19ebdd2025-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: venlafaxine hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.15c77ad7-7edc-4c36-ba3f-3ef05dfb12dc2025-02-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAvPAK2efde38c-250e-d1b9-e063-6394a90a1b742025-02-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINEPreferred Pharmaceuticals Inc.edefc932-d25d-4ead-b348-b3b6d92320912025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2cf6e6ad-7d00-0db1-e063-6394a90ab1ec2025-01-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2c2bb0e6-5a73-ff57-e063-6294a90a88d32025-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDEVENLAFAXINEBluePoint Laboratories5efe1336-c796-4560-8110-a64c80eefb0c2025-01-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: VENLAFAXINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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