Application 019680

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEPAKOTE	DIVALPROEX SODIUM	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 125MG VALPROIC ACID	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N019680-001	DEPAKOTE	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019680-001	AB

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019680-001	DEPAKOTE	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1989-09-12	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019680-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019680-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019680-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019680-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019680-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019680-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019680-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019680-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019680-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019680-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019680-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019680-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019680-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019680-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019680-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019680-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019680-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019680-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019680-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019680-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019680-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019680-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019680-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019680-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019680-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019680-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019680-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019680-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019680-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019680-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019680-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019680-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019680-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019680-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019680-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019680-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019680-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019680-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019680-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019680-001	AB	1	`e64feba35796…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Depakote Sprinkles	DIVALPROEX SODIUM	AbbVie Inc.	4619aff4-0f80-444f-858d-42e4137aa809	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019680 application number: NDA019680 ndc (product): 0074-6114

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-6114	Depakote	Divalproex Sodium	AbbVie Inc.	NDA	Current
0074-6114	Depakote	Divalproex Sodium	AbbVie Inc.	NDA	Current
0074-6114	Depakote	Divalproex Sodium	AbbVie Inc.	NDA	Current
0074-6114	Depakote	Divalproex Sodium	AbbVie Inc.	NDA	Current
0074-6114	Depakote	Divalproex Sodium	AbbVie Inc.	NDA	Current
0074-6114	Depakote	Divalproex Sodium	AbbVie Inc.	NDA	Current
0074-6114	Depakote	Divalproex Sodium	AbbVie Inc.	NDA	Current
0074-6114	Depakote	Divalproex Sodium	AbbVie Inc.	NDA	Current
0074-6114	Depakote	Divalproex Sodium	AbbVie Inc.	NDA	Current
0781-2243	Divalproex Sodium	Divalproex Sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2243	Divalproex Sodium	Divalproex Sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2243	Divalproex Sodium	Divalproex Sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2243	Divalproex Sodium	Divalproex Sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2243	Divalproex Sodium	Divalproex Sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2243	Divalproex Sodium	Divalproex Sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2243	Divalproex Sodium	Divalproex Sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85627	SUPPL	2026-04-02
85622	SUPPL	2026-04-02
82132	SUPPL	2025-05-05
82173	SUPPL	2025-05-01
81057	SUPPL	2025-02-06
81044	SUPPL	2025-02-06
81043	SUPPL	2025-02-06
77903	SUPPL	2024-03-21
77876	SUPPL	2024-03-19
73629	SUPPL	2023-02-28
73613	SUPPL	2023-02-27
69461	SUPPL	2021-12-03
69460	SUPPL	2021-12-03
69437	SUPPL	2021-12-01
66258	SUPPL	2021-02-17
66257	SUPPL	2021-02-17
66198	SUPPL	2021-02-11
63198	SUPPL	2020-05-20
63197	SUPPL	2020-05-20
63160	SUPPL	2020-05-20
61222	SUPPL	2019-12-10
61221	SUPPL	2019-12-10
61059	SUPPL	2019-11-26
57780	SUPPL	2019-02-22
57763	SUPPL	2019-02-22
54088	SUPPL	2018-05-10
54068	SUPPL	2018-05-10
50001	SUPPL	2017-10-10
49982	SUPPL	2017-10-06
47506	SUPPL	2017-03-08
47481	SUPPL	2017-03-07
45842	SUPPL	2016-11-08
45813	SUPPL	2016-11-04
33867	SUPPL	2016-02-23
19096	SUPPL	2016-02-23
33866	SUPPL	2015-10-06
1503	SUPPL	2015-09-25
33865	SUPPL	2015-03-17
1502	SUPPL	2015-03-17
33863	SUPPL	2015-01-08
19094	SUPPL	2015-01-08
33862	SUPPL	2014-12-03
19093	SUPPL	2014-11-24
33864	SUPPL	2014-08-22
19095	SUPPL	2014-08-21
33860	SUPPL	2014-06-23
19091	SUPPL	2014-06-23
19089	SUPPL	2014-06-23
11630	SUPPL	2014-06-23
1501	SUPPL	2014-06-11
11634	SUPPL	2014-06-10
33861	SUPPL	2013-09-17
1500	SUPPL	2013-09-17
11633	SUPPL	2013-07-02
11632	SUPPL	2013-03-04
19092	SUPPL	2013-03-01
19090	SUPPL	2011-10-13
19088	SUPPL	2011-10-13
1499	SUPPL	2011-10-13
1498	SUPPL	2011-10-13
33859	SUPPL	2011-10-12
33858	SUPPL	2011-10-12
11631	SUPPL	2011-10-12
11629	SUPPL	2011-10-12
11628	SUPPL	2009-05-07
1497	SUPPL	2009-05-01
23550	ORIG	2008-02-01
1495	SUPPL	2006-12-28
33857	SUPPL	2006-12-26
1496	SUPPL	2006-10-23
11627	SUPPL	2006-10-18
1494	SUPPL	2006-01-20
11626	SUPPL	2006-01-13
1493	SUPPL	2004-06-02