Application 077296

Type
ANDA
Sponsor
CELLTRION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIVALPROEX SODIUMDIVALPROEX SODIUMTABLET, DELAYED RELEASE;ORALEQ 125MG VALPROIC ACIDNoNo
002DIVALPROEX SODIUMDIVALPROEX SODIUMTABLET, DELAYED RELEASE;ORALEQ 250MG VALPROIC ACIDNoNo
003DIVALPROEX SODIUMDIVALPROEX SODIUMTABLET, DELAYED RELEASE;ORALEQ 500MG VALPROIC ACIDNoNo

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
A077296-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31
A077296-002DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31
A077296-003DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077296-001AB
A077296-002AB
A077296-003AB

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-3184e616aacf4f…
2026-08-18 06:07:402026-07A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077296-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077296-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077296-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077296-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077296-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077296-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077296-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077296-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077296-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077296-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077296-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077296-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077296-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077296-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077296-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077296-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077296-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077296-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077296-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077296-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077296-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077296-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077296-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077296-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077296-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077296-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077296-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077296-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077296-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077296-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077296-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077296-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077296-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077296-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077296-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077296-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077296-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077296-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077296-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077296-001AB1301d65b070ca…

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 4 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Depakote ERDIVALPROEX SODIUMAbbVie Inc.0dc024ce-efc8-4690-7cb5-639c728fccac2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
DepakoteDIVALPROEX SODIUMAbbVie Inc.08a65cf4-7749-4ceb-6895-8f4805e2b01f2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Depakote SprinklesDIVALPROEX SODIUMAbbVie Inc.4619aff4-0f80-444f-858d-42e4137aa8092026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMA-S Medication Solutions3df910c5-b6f0-4a65-9640-b702ecea49f92026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex sodium
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMA-S Medication Solutions94eac383-a89f-4128-b81c-076640b8edcf2026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex sodium
generic name: DIVALPROEX SODIUM
DIVALPROEX SODIUMDIVALPROEX SODIUMDirectRxce12c7b1-caa9-4224-bb5f-3e20e0281d662026-03-17WarningsName fallback
brand name: DIVALPROEX SODIUM
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepackc971b50d-0f78-422f-abee-1c5b4e1d20e72026-03-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: divalproex sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMSafecor Health, LLC3aec1944-86a1-490c-a734-d9dd3b52c9d62026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMPreferred Pharmaceuticals Inc.dbd1d178-77a3-46ff-985d-307dffaed1ad2026-02-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: divalproex sodium
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMCoupler LLC4834732f-6044-946c-e063-6394a90a5da32026-01-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: divalproex sodium
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMAmerican Health Packagingb12b76a0-4b6e-4cd4-9508-10a2c84d8beb2026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: divalproex sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMAvPAKe8cc336b-5191-7f8b-e053-2a95a90a6acb2026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMA-S Medication Solutionse5fcf5b1-263e-43e0-9424-e613d5cca3fa2026-01-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: divalproex sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMNorthwind Health Company, LLCab6fa448-7485-6644-e053-2a95a90aa1812026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMCoupler LLC46b2e8a9-5d50-d0b2-e063-6294a90a1b472025-12-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: divalproex sodium
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepack0669ac77-10df-48af-bc42-55e768b69e4f2025-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMAmerican Health Packaginga8ba3986-1ded-44a8-8d10-d0f252a077942025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMUpsher-Smith Laboratories, LLC02304a23-4a5f-47bc-9687-4044b43f7a202025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMMajor Pharmaceuticalsfb39a94e-93e6-4afe-a300-f80e8f1e0fa62025-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMNCS HealthCare of KY, LLC dba Vangard Labsf936b9d0-a58f-4fa5-8db9-752dabb837a62025-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: divalproex sodium
generic name: DIVALPROEX SODIUM

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-973DIVALPROEX SODIUMDIVALPROEX SODIUMWOCKHARDT LIMITEDANDACurrent
55648-974DIVALPROEX SODIUMDIVALPROEX SODIUMWOCKHARDT LIMITEDANDACurrent
55648-975DIVALPROEX SODIUMDIVALPROEX SODIUMWOCKHARDT LIMITEDANDACurrent
64679-973DIVALPROEX SODIUMDIVALPROEX SODIUMWockhardt USA LLC.ANDACurrent
64679-974DIVALPROEX SODIUMDIVALPROEX SODIUMWockhardt USA LLC.ANDACurrent
64679-975DIVALPROEX SODIUMDIVALPROEX SODIUMWockhardt USA LLC.ANDACurrent