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 6 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.6cb943a8-5972-292f-e053-2991aa0ae3ee2024-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: venlafaxine hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC19b1543e-d599-a869-e063-6294a90a8e282024-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackbff505db-2752-41fc-a4dd-4773f629106e2024-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack04340ccb-c3b3-41ab-a4bc-101d8b6bc1a92024-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEQUALLENT PHARMACEUTICALS HEALTH LLCcb4c04a6-47d1-44ff-8d58-718102fa08eb2024-05-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxineVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack304bda24-9151-47b5-9f62-005ea325a11e2024-05-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAurobindo Pharma Limited85d3ce8b-8966-45d9-bdaf-f6f0475096e12024-04-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack1a9e207a-aba5-4ecb-b7b6-7c1e38be5ac92024-04-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.9a30e1b5-272b-4109-ad6c-a3c9a895822f2024-03-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionsdf7e0982-3eb0-4bdf-8f7f-4f4a48476ed72023-11-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LP5c558ab8-b4b3-4973-b016-ed5cfcb4d88b2023-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxineVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack49e5833b-4693-45b5-9abb-1b369eb4086d2023-10-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Lifesciences Limited1be1be3a-304b-4e31-8732-3352470291912023-09-28Name fallback
brand name: venlafaxine hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.dc989aa7-c4ab-4359-a971-523eb477ef9b2023-09-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionse1114c1d-c193-4c0c-ad1c-c17b3fc617232023-09-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.37aaa8ac-4e0c-4e04-98b5-19b0d90d857c2023-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Venlafaxine Hydrochloride
generic name: VENLAFAXINE HYDROCHLORIDE
VenlafaxineVENLAFAXINE HYDROCHLORIDEAurobindo Pharma Limitedb23637e5-d37f-41b5-ba76-fc053e903bc22023-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxineVENLAFAXINE HYDROCHLORIDERising Pharma Holdings, Inc.20319949-ccf9-477a-a6e3-53502772deb92023-08-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Effexor XRVENLAFAXINE HYDROCHLORIDEViatris Specialty LLCc848a5d8-ba94-4c84-80e3-0bf35fb8e32e2023-08-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions52319578-f7cc-4b87-b532-f341854e40b42023-07-22Boxed 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.