Application 076941

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, DELAYED RELEASE;ORAL	EQ 125MG VALPROIC ACID	No	No
002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, DELAYED RELEASE;ORAL	EQ 250MG VALPROIC ACID	No	No
003	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, DELAYED 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076941-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29
A076941-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29
A076941-003	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076941-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076941-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076941-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076941-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076941-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076941-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076941-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076941-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076941-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076941-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076941-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076941-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076941-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076941-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076941-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076941-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076941-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076941-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076941-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076941-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076941-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076941-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076941-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076941-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076941-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076941-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076941-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2008-07-29	`301d65b070ca…`

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	A076941-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076941-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076941-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076941-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076941-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076941-003	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 3 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	Rising Pharma Holdings, Inc.	6316061c-9758-4f38-9cb2-7ca833dd20bf	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Lupin Pharmaceuticals, Inc.	33798a7c-c5a9-49a5-be5d-1312910ef468	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Lupin Pharmaceuticals, Inc.	1f081c74-9f73-4ed9-9157-8d73d586a409	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	cf15569c-5010-4e9b-aef0-7df4de5ed04e	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	ab8616a5-ea72-4df7-b095-54ea19ef6fba	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	ed24bb3a-bba1-4b27-8733-96619793fc15	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	Bionpharma Inc.	19064624-81d1-4ce3-bfe4-955bad6af6a2	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	First Nation Group, LLC	a76f9909-28c9-4eb7-8ffd-ff6222fea079	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Cardinal Health 107, LLC	283af6d2-8ea2-4225-b2e7-a2057dbdb793	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Sun Pharmaceutical Industries, Inc.	64797788-fdcb-4d12-a1a4-743ad71bd17b	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Unichem Pharmaceuticals (USA), Inc.	1ec1a441-218a-4c80-a0cb-69bcc327f472	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Preferred Pharmaceuticals Inc.	dc9e4871-fb3d-4c59-81e5-2ab6e8be9b7c	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	Lifestar Pharma LLC	b2388bfd-7455-48ae-b396-463df0c278f0	2026-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Dr. Reddy's Laboratories Ltd	f911748c-fb3a-fe1a-ab2a-4b40455e05ef	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Alembic Pharmaceuticals Inc.	fea19b14-d8ed-4954-bc54-b9240f78b3c3	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Preferred Pharmaceuticals, Inc.	83a77f60-ed58-4fa0-a584-e6a0c767d19d	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Preferred Pharmaceuticals Inc.	d1d4d790-73d5-4a3b-a786-99f2c9812546	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	Zydus Pharmaceuticals USA Inc.	ed710c62-8ba6-4f19-b240-3ee73cd03d67	2026-04-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Aurobindo Pharma Limited	dbd47222-14f1-4588-a009-9b81b55ca60d	2026-04-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Amneal Pharmaceuticals LLC	7d3352ee-a240-43ff-a243-29ad2bc989c7	2026-04-04	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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7439	Divalproex Sodium	Divalproex Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7440	Divalproex Sodium	Divalproex Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7441	Divalproex Sodium	Divalproex Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39520	ORIG	2008-11-20
31177	ORIG	2008-08-01