FDA.reportPublic FDA data

Application 020151

Type
NDA
Sponsor
WYETH PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EFFEXORVENLAFAXINE HYDROCHLORIDETABLET;ORALEQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002EFFEXORVENLAFAXINE HYDROCHLORIDETABLET;ORALEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003EFFEXORVENLAFAXINE HYDROCHLORIDETABLET;ORALEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004EFFEXORVENLAFAXINE HYDROCHLORIDETABLET;ORALEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005EFFEXORVENLAFAXINE HYDROCHLORIDETABLET;ORALEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
006EFFEXORVENLAFAXINE HYDROCHLORIDETABLET;ORALEQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020151-001EFFEXORVENLAFAXINE HYDROCHLORIDEEQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28
N020151-002EFFEXORVENLAFAXINE HYDROCHLORIDEEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28
N020151-003EFFEXORVENLAFAXINE HYDROCHLORIDEEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28
N020151-004EFFEXORVENLAFAXINE HYDROCHLORIDEEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28
N020151-005EFFEXORVENLAFAXINE HYDROCHLORIDEEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28
N020151-006EFFEXORVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020151-001EFFEXOREQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-2884e616aacf4f…
2026-09-14 22:38:342026-08N020151-002EFFEXOREQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-2884e616aacf4f…
2026-09-14 22:38:342026-08N020151-003EFFEXOREQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-2884e616aacf4f…
2026-09-14 22:38:342026-08N020151-004EFFEXOREQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-2884e616aacf4f…
2026-09-14 22:38:342026-08N020151-005EFFEXOREQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-2884e616aacf4f…
2026-09-14 22:38:342026-08N020151-006EFFEXOREQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-2884e616aacf4f…
2026-08-18 06:07:402026-07N020151-001EFFEXOREQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07N020151-002EFFEXOREQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07N020151-003EFFEXOREQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07N020151-004EFFEXOREQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07N020151-005EFFEXOREQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07N020151-006EFFEXOREQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020151-001EFFEXOREQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020151-002EFFEXOREQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020151-003EFFEXOREQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020151-004EFFEXOREQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020151-005EFFEXOREQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020151-006EFFEXOREQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020151-001EFFEXOREQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020151-002EFFEXOREQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020151-003EFFEXOREQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020151-004EFFEXOREQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020151-005EFFEXOREQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020151-006EFFEXOREQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020151-001EFFEXOREQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020151-002EFFEXOREQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020151-003EFFEXOREQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020151-004EFFEXOREQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020151-005EFFEXOREQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020151-006EFFEXOREQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020151-001EFFEXOREQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020151-002EFFEXOREQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020151-003EFFEXOREQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020151-004EFFEXOREQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020151-005EFFEXOREQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020151-006EFFEXOREQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020151-001EFFEXOREQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020151-002EFFEXOREQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020151-003EFFEXOREQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020151-004EFFEXOREQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-12-28b8a1b40f171c…

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 2 of 7 · 130 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDENorthStar RxLLCb865c175-e75d-4cb4-ac29-dec72226302c2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEMacleods Pharmaceuticals Limited3e51f786-3691-4ec4-836b-7f2c9a385aa72026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAsclemed USA, Inc.c69d16fd-b82d-4708-aece-ab4f60b29cc62026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack7aa3edba-4248-49bb-86f7-06fdbf2a6fb72026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepacke2fa1bb0-ab86-4499-84cb-ff5e02a169912026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.1775b8bf-cd4f-4a8a-abd1-78d90de54fdd2026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEGranules Pharmaceuticals Inc.67059969-e291-4609-b130-0faacf2a19f02026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2a7d760c-fd9f-8026-e063-6294a90aaa432026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions7852be9e-0c1d-47a8-9513-c3a04b3657632026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions28c8f404-1dbd-4140-8959-32624d7c77242026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions296d6ab7-8c0c-40e5-8cb2-9d125b42b8bb2026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECardinal Health 107, LLC7588ffdc-034d-4baf-9889-9a0ded265be52026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions33068acd-d361-4cd9-b994-02a7865ff04f2026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions812ca864-8230-4c84-a7f4-d1b926dee31a2026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions569e10d1-6432-473c-a026-ac438bd77bcd2026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.c0fa9a3b-692e-2c2e-e053-2995a90aa83a2026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEEpic Pharma, LLC430777f0-347c-4f21-8c5d-55f4e9897e742026-02-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.ddb51556-0292-4aa9-b781-a402c912591f2026-02-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackd7d1319c-500e-4ca0-83a1-a739cfa01cf72026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECoupler LLC4a007068-89d9-c296-e063-6394a90ad6d02026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VENLAFAXINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
46125SUPPL2016-12-09
2086SUPPL2012-12-19
2084SUPPL2012-12-19
2082SUPPL2012-12-19
2071SUPPL2012-12-19
34312SUPPL2012-12-13
34301SUPPL2012-12-13
12258SUPPL2012-12-13
12256SUPPL2012-12-13
2085SUPPL2012-05-09
12259SUPPL2012-05-07
2080SUPPL2010-01-19
21218SUPPL2010-01-14
2083SUPPL2010-01-14
34311SUPPL2010-01-08
12257SUPPL2010-01-08
34310SUPPL2009-11-13
12255SUPPL2009-02-04
2081SUPPL2009-02-03
34308SUPPL2008-11-20
21216SUPPL2008-05-28
34309SUPPL2008-02-14
21217SUPPL2008-02-14
2075SUPPL2008-02-05
20486SUPPL2007-11-19
20485SUPPL2007-11-19
20484SUPPL2007-11-19
34307SUPPL2007-09-26
34306SUPPL2007-09-26
2079SUPPL2007-09-25
2078SUPPL2007-09-25
34305SUPPL2007-08-02
21215SUPPL2007-08-02
12254SUPPL2007-08-02
41158SUPPL2007-07-06
20480SUPPL2007-07-06
41161SUPPL2007-07-05
41160SUPPL2007-07-05
41159SUPPL2007-07-05
41157SUPPL2007-07-05
20483SUPPL2007-07-05
20482SUPPL2007-07-05
20481SUPPL2007-07-05
34302SUPPL2007-02-21
2076SUPPL2007-02-12
34304SUPPL2006-10-23
2077SUPPL2006-10-23
21214SUPPL2006-09-20
34303SUPPL2006-09-15
2073SUPPL2006-03-01
21213SUPPL2006-01-20
2074SUPPL2006-01-20
23569ORIG2005-04-15
21212SUPPL2005-02-23
34299SUPPL2004-06-02
34300SUPPL2004-05-27
12253SUPPL2004-05-27
12252SUPPL2004-05-27
21211SUPPL2004-05-26
2072SUPPL2004-05-26
2070SUPPL2004-05-26
2068SUPPL2004-05-07
2069SUPPL2004-04-20
21210SUPPL2004-03-24
2067SUPPL2003-07-30
2066SUPPL2003-07-30
12251SUPPL2003-04-24
53536SUPPL1900-01-01
53535SUPPL1900-01-01
52225SUPPL1900-01-01
52223SUPPL1900-01-01
52222SUPPL1900-01-01