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 1.

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077296-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077296-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077296-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-318072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077296-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077296-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077296-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077296-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077296-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077296-001AB18072bd15b7f6…

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 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.0339e27d-3dbf-4c37-a14e-f53557c08e192026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.5926c3ff-c995-4789-941c-d38aa7db94dc2026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.90225548-85a8-4ea7-95d3-e8231c36fe5a2026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.a67855ff-a879-43f0-bca3-94c304348bf52026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.392df14f-4d65-4be9-973b-1f0ce1013d8f2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.33f07aac-4dc5-4f97-976a-a84f93497bc62026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.3b41cd15-9981-4d44-9c4b-e84168d864532026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMDr. Reddy's Laboratories Ltdfa823ee0-0c69-6b85-da1e-9bb2e2150ea52026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMDr. Reddy's Laboratories Ltd2e35f833-1cf7-12eb-9567-7a191e32e1382026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMCoupler LLC55f1614b-aadc-34ca-e063-6394a90ae2a72026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: divalproex sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMMajor Pharmaceuticals4ef6c5fd-42b2-4419-9b5a-e6d63571e3a02026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMCamber Pharmaceuticals, Inc.e8e954d4-54e3-491c-867c-b3b656b70f232026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.74a9f020-f7a1-44e2-a452-f0e37bd3e0772026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMSt. Mary's Medical Park Pharmacy35a91dd3-19d0-09cb-e063-6394a90af01b2026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMSt. Mary's Medical Park Pharmacy35a95333-9fc1-7a9f-e063-6294a90a9f302026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMMajor Pharmaceuticals4a0fa934-ec8c-460e-86eb-11281728fe852026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex sodium
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMUnichem Pharmaceuticals (USA), Inc.1d4129ae-0ce8-4a04-9f9d-c770508de8ed2026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: divalproex sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMUnit Dose Solutions, Inc.547d8305-bfc5-f4da-e063-6294a90a61062026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMCardinal Health 107, LLC4fc50afb-67f3-4bf3-9ec3-cc12734f47fd2026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex Sodium
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMNorthStar Rx LLCaab6b411-11e9-4a16-afb6-d471ba4756e92026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Divalproex sodium
generic name: DIVALPROEX SODIUM

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