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 4 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Depakote ER	DIVALPROEX SODIUM	AbbVie Inc.	0dc024ce-efc8-4690-7cb5-639c728fccac	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIVALPROEX SODIUM
Depakote	DIVALPROEX SODIUM	AbbVie Inc.	08a65cf4-7749-4ceb-6895-8f4805e2b01f	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIVALPROEX SODIUM
Depakote Sprinkles	DIVALPROEX SODIUM	AbbVie Inc.	4619aff4-0f80-444f-858d-42e4137aa809	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	A-S Medication Solutions	3df910c5-b6f0-4a65-9640-b702ecea49f9	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	A-S Medication Solutions	94eac383-a89f-4128-b81c-076640b8edcf	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
DIVALPROEX SODIUM	DIVALPROEX SODIUM	DirectRx	ce12c7b1-caa9-4224-bb5f-3e20e0281d66	2026-03-17	Warnings	Name fallback brand name: DIVALPROEX SODIUM generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	c971b50d-0f78-422f-abee-1c5b4e1d20e7	2026-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Safecor Health, LLC	3aec1944-86a1-490c-a734-d9dd3b52c9d6	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	Preferred Pharmaceuticals Inc.	dbd1d178-77a3-46ff-985d-307dffaed1ad	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	Coupler LLC	4834732f-6044-946c-e063-6394a90a5da3	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	American Health Packaging	b12b76a0-4b6e-4cd4-9508-10a2c84d8beb	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	AvPAK	e8cc336b-5191-7f8b-e053-2a95a90a6acb	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	A-S Medication Solutions	e5fcf5b1-263e-43e0-9424-e613d5cca3fa	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Northwind Health Company, LLC	ab6fa448-7485-6644-e053-2a95a90aa181	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	Coupler LLC	46b2e8a9-5d50-d0b2-e063-6294a90a1b47	2025-12-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	0669ac77-10df-48af-bc42-55e768b69e4f	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	American Health Packaging	a8ba3986-1ded-44a8-8d10-d0f252a07794	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Upsher-Smith Laboratories, LLC	02304a23-4a5f-47bc-9687-4044b43f7a20	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Major Pharmaceuticals	fb39a94e-93e6-4afe-a300-f80e8f1e0fa6	2025-11-21	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	f936b9d0-a58f-4fa5-8db9-752dabb837a6	2025-11-14	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