Application 078700

Type: ANDA
Sponsor: ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, EXTENDED RELEASE;ORAL	EQ 500MG VALPROIC ACID	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078700-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL			2009-08-03

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078700-001	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-03	`f41ea6bd6efb…`

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 6 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	48a6e47a-3697-492d-9086-56e4ca0151e5	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	c8d9cd69-ceca-3057-9d1c-12c44b19f767	2025-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	BluePoint Laboratories	1b12c694-e120-45f6-ad28-36373e2c5378	2025-03-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	0fb57229-08ef-44d6-b40a-92b2f96ff795	2025-02-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	American Health Packaging	64b509bc-f398-48ad-bdcb-9904e61d9225	2025-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Alembic Pharmaceuticals Limited	f34c4504-5409-406e-995b-138e5f700242	2025-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	NuCare Pharmaceuticals,Inc.	0bef10ed-e4b5-95ae-e063-6294a90a86eb	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	Zydus Lifesciences Limited	b0f33792-dd96-40cc-a28e-acdcdca2f4b8	2024-11-28		Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	A-S Medication Solutions	c8f72850-92d5-4f64-b9f1-657f72bfa15a	2024-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	388fd4bc-f12f-4e55-a1e7-72aa585519fa	2024-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	319bbead-bec8-4bb7-9ecb-b2e161c44b8d	2024-09-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	9a9f5f24-e421-406f-ac91-d1f964245f54	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	A-S Medication Solutions	8ecfe765-d743-4308-9cd9-4a7b1a229ea9	2024-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	A-S Medication Solutions	63d61062-2700-47f4-8ab4-3bd641b81fe1	2024-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	bf34dd25-abe3-4587-b481-df052f085429	2023-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	0f5bb45e-836b-48ce-9764-2d50edcb202c	2023-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Hahnemann Laboratories, INC.	f7fec516-ec6f-6248-e053-6294a90a3342	2023-03-28		Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Proficient Rx LP	abac11e6-7ce1-491c-9ac3-61f3df54c4a4	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Hahnemann Laboratories, INC.	e3281609-460a-4982-e053-2995a90a01c5	2022-07-06		Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	177e34e9-f74d-42aa-8e3c-5fb4f41c2322	2018-12-19	Boxed warning, Warnings, Adverse reactions	Name 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.