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 5 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine hydrochloride ERVENLAFAXINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf8fd4381-52f2-d9c1-e053-6394a90a08e52024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine Hydrochloride ERVENLAFAXINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf7a9741b-2dd3-d8f3-e053-6294a90a4d732024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine hydrochloride ERVENLAFAXINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf89bcae0-e714-599a-e053-6294a90a2c3a2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2a85bd43-419c-6ed7-e063-6294a90a84d42024-12-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals Inc.2787aaa2-5210-f7d5-e063-6294a90a71032024-11-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8906ed5a-f69c-0eac-e053-2995a90ae6002024-11-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack20a7d922-7f7c-4de4-b5fd-55c13aab060c2024-10-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LP9f697c00-f5ec-454a-a66c-503aef5fc6092024-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LP613658d3-7eb5-4822-961f-f4c6f6b2a2c12024-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LPadeba7dd-bd15-4d8f-b703-24c3a208e7402024-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackbaae24d6-e425-4cfc-9a53-3cd223b6d3442024-09-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack1e1119f7-0c2e-4587-a24d-0066f73b2e652024-09-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Lifesciences Limited51334651-7a7f-4653-bf9d-d5be04fd902d2024-08-14Name fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECamber Pharmaceuticals, Inc.0ee91447-2c23-4519-81cc-550b5416dd6b2024-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.1e04fe02-88c9-dafd-e063-6294a90ac4c92024-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1bf78b22-a0e3-5f9f-e063-6394a90a30242024-06-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.9d38eac0-9d64-1274-e053-2995a90a189a2024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8f9d3d30-e9a6-6c85-e053-2a95a90a55242024-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs9c061460-3b80-41e1-a87a-1a25108ff7402024-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEAlembic Pharmaceuticals Limitede3e238db-4388-49bb-aa67-6d73adbb22802024-06-11Boxed 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.