FDA.reportPublic FDA data

Application 218793

Type
ANDA
Sponsor
ALEMBIC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIVALPROEX SODIUMDIVALPROEX SODIUMCAPSULE, DELAYED REL PELLETS;ORALEQ 125MG VALPROIC ACIDNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218793-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2024-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218793-001AB

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
2026-02-19 14:30 UTC2026-02A218793-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2024-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218793-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2024-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A218793-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2024-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218793-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2024-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218793-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2024-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218793-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2024-12-1903ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218793-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2024-12-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218793-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218793-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218793-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218793-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218793-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218793-001AB103ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218793-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex sodiumDIVALPROEX SODIUMAlembic Pharmaceuticals Inc.fea19b14-d8ed-4954-bc54-b9240f78b3c32026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218793
application number: ANDA218793
Divalproex sodiumDIVALPROEX SODIUMAlembic Pharmaceuticals Limitedf34c4504-5409-406e-995b-138e5f7002422025-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218793
application number: ANDA218793