Application 078445

Type: ANDA
Sponsor: ANCHEN PHARMS

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 250MG VALPROIC ACID	No	No
002	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078445-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL			2009-02-26
A078445-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL			2009-08-04

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 3 · 86 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	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A078445-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078445-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078445-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078445-002	AB	1	`ea99ee380514…`

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 2 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	Camber Pharmaceuticals, Inc.	e8e954d4-54e3-491c-867c-b3b656b70f23	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	74a9f020-f7a1-44e2-a452-f0e37bd3e077	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	St. Mary's Medical Park Pharmacy	35a91dd3-19d0-09cb-e063-6394a90af01b	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	St. Mary's Medical Park Pharmacy	35a95333-9fc1-7a9f-e063-6294a90a9f30	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Major Pharmaceuticals	4a0fa934-ec8c-460e-86eb-11281728fe85	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	Unichem Pharmaceuticals (USA), Inc.	1d4129ae-0ce8-4a04-9f9d-c770508de8ed	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Unit Dose Solutions, Inc.	547d8305-bfc5-f4da-e063-6294a90a6106	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Cardinal Health 107, LLC	4fc50afb-67f3-4bf3-9ec3-cc12734f47fd	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	NorthStar Rx LLC	aab6b411-11e9-4a16-afb6-d471ba4756e9	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	41e32cd5-1393-4ef1-81cb-8e3795e30682	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	a999f402-be1d-4153-b743-cfdb95ed1562	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	7ead614c-a68d-4a2f-94d0-e6404a8f8760	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	6af40b06-0a92-454c-9277-80e89de27231	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Coupler LLC	533245ba-7088-c929-e063-6294a90abe1d	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Cardinal Health 107, LLC	8e86a610-45ef-4be7-a3ab-f656f5b32706	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	A-S Medication Solutions	79132bea-04d8-4dd9-bd31-07f0ba805c21	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	beba3da1-e80d-45b4-9bd6-3ed85c9482f3	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	BluePoint Laboratories	b95494e2-ee7a-7415-e053-2995a90ae852	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Ajanta Pharma USA Inc.	773a289b-65ed-4045-80c5-f00e28c1c079	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	NorthStar Rx LLC	589ae3a6-8b2e-d931-d36b-1937287ab5c0	2026-05-20	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10370-510	Divalproex Sodium	Divalproex Sodium	Par Pharmaceutical, Inc.	ANDA	Current
10370-510	Divalproex Sodium	Divalproex Sodium	Par Pharmaceutical, Inc.	ANDA	Current
10370-510	Divalproex Sodium	Divalproex Sodium	Par Pharmaceutical, Inc.	ANDA	Current
10370-511	Divalproex Sodium	Divalproex Sodium	Par Pharmaceutical, Inc.	ANDA	Current
10370-511	Divalproex Sodium	Divalproex Sodium	Par Pharmaceutical, Inc.	ANDA	Current
10370-511	Divalproex Sodium	Divalproex Sodium	Par Pharmaceutical, Inc.	ANDA	Current
43063-295	Divalproex Sodium	Divalproex Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-295	Divalproex Sodium	Divalproex Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-295	Divalproex Sodium	Divalproex Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-3913	Divalproex Sodium	Divalproex Sodium	A-S Medication Solutions	ANDA	Current
67046-143	Divalproex Sodium	Divalproex Sodium	Contract Pharmacy Services-PA	ANDA	Current
70518-1498	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1498	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2497	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current