FDA.reportPublic FDA data

Application 220460

Type
ANDA
Sponsor
YICHANG HUMANWELL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 25MG BASENoNo
002DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 50MG BASENoNo
003DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 100MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220460-001DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-10
A220460-002DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-10
A220460-003DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A220460-001AB
A220460-002AB
A220460-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A220460-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-1084e616aacf4f…
2026-09-14 22:38:342026-08A220460-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-1084e616aacf4f…
2026-09-14 22:38:342026-08A220460-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-1084e616aacf4f…
2026-08-18 06:07:402026-07A220460-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-10caaa826d4ba7…
2026-08-18 06:07:402026-07A220460-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-10caaa826d4ba7…
2026-08-18 06:07:402026-07A220460-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-10caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220460-001DESVENLAFAXINE SUCCINATEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220460-002DESVENLAFAXINE SUCCINATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220460-003DESVENLAFAXINE SUCCINATEEQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220460-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A220460-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A220460-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A220460-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A220460-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A220460-003AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220460-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220460-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220460-003AB1a50c72e98297…

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 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesvenlafaxineDESVENLAFAXINE SUCCINATEBreckenridge Pharmaceutical, Inc25bdfc41-c7cb-4d16-b6a8-f102f9b8c9842026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEBryant Ranch Prepack56c9e8ee-1460-4a4c-8033-65d9afb358c82026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Desvenlafaxine Succinate
generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEBryant Ranch Prepack593d340b-f49a-455b-aeb2-5a1eaf7b6cbe2026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Desvenlafaxine Succinate
generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEA-S Medication Solutions5755f1b2-c10b-47f6-a08d-38d1c05bd3532026-05-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Desvenlafaxine Succinate
generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEBryant Ranch Prepack5f349cc5-b803-462d-b323-d681bd1a02f02026-05-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Desvenlafaxine Succinate
generic name: DESVENLAFAXINE SUCCINATE
Pristiq Extended-ReleaseDESVENLAFAXINE SUCCINATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.0f43610c-f290-46ea-d186-4f998ed99fce2026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESVENLAFAXINE SUCCINATE
DesvenlafaxineDESVENLAFAXINE SUCCINATEPreferred Pharmaceuticals Inc.b4a5efab-3765-4ea5-a8cd-66e67e76c8452026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEPreferred Pharmaceuticals Inc.453a5759-2f0d-421d-be78-81ab97c8ce772026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Desvenlafaxine Succinate
generic name: DESVENLAFAXINE SUCCINATE
DesvenlafaxineDESVENLAFAXINE SUCCINATEPreferred Pharmaceutical, Inc.4b786ea1-309d-440c-b091-38d6b1f7fbd32026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATELupin Pharmaceuticals, Inc.e96272a2-8f73-4fbe-a8d4-a78d4ad688312025-12-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Desvenlafaxine Succinate
generic name: DESVENLAFAXINE SUCCINATE
DesvenlafaxineDESVENLAFAXINE SUCCINATECoupler LLC325be002-4db2-40e9-e063-6394a90ae94e2025-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESVENLAFAXINE SUCCINATE
desvenlafaxineDESVENLAFAXINE SUCCINATEDIRECT RXb3ef2bb2-c336-2d57-e053-2995a90a5fe02025-01-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEA-S Medication Solutions7ee04e8c-ce6c-450d-9122-2bffd170bfd72024-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Desvenlafaxine Succinate
generic name: DESVENLAFAXINE SUCCINATE
DesvenlafaxineDESVENLAFAXINE SUCCINATEBryant Ranch Prepack5e78c812-7fe6-4a4e-8465-0415df2e98512024-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESVENLAFAXINE SUCCINATE
Desvenlafaxine SuccinateDESVENLAFAXINE SUCCINATEMacleods Pharmaceuticals Limitededf18b33-a226-44f8-9f42-c409e691ee642024-08-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Desvenlafaxine Succinate
generic name: DESVENLAFAXINE SUCCINATE
DesvenlafaxineDESVENLAFAXINE SUCCINATEA-S Medication Solutions88ac1206-864b-47a3-82ab-be83bc9532f32023-09-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESVENLAFAXINE SUCCINATE
DesvenlafaxineDESVENLAFAXINE SUCCINATEA-S Medication Solutionsb2a3edb8-ba64-4ead-b452-d6c8dbaba91d2023-02-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESVENLAFAXINE SUCCINATE
DesvenlafaxineDESVENLAFAXINE SUCCINATEProficient Rx LPd4542c5e-f9e8-49c7-afa6-9dd4c4d485f22023-02-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESVENLAFAXINE SUCCINATE
DesvenlafaxineDESVENLAFAXINE SUCCINATEAlembic Pharmaceuticals Limited5bd203d2-477e-4d12-a875-cb8009f424102023-01-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DESVENLAFAXINE SUCCINATE

Reported adverse events (FAERS/openFDA)#

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