Application 020593

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEPACON	VALPROATE SODIUM	INJECTABLE;INJECTION	EQ 100MG BASE/ML	Yes	No

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
N020593-001	DEPACON	VALPROATE SODIUM	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-12-30

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020593-001	DEPACON	EQ 100MG BASE/ML	INJECTABLE / INJECTION	RLD	1996-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020593-001	DEPACON	EQ 100MG BASE/ML	INJECTABLE / INJECTION	RLD	1996-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020593-001	DEPACON	EQ 100MG BASE/ML	INJECTABLE / INJECTION	RLD	1996-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020593-001	DEPACON	EQ 100MG BASE/ML	INJECTABLE / INJECTION	RLD	1996-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020593-001	DEPACON	EQ 100MG BASE/ML	INJECTABLE / INJECTION	RLD	1996-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020593-001	DEPACON	EQ 100MG BASE/ML	INJECTABLE / INJECTION	RLD	1996-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020593-001	DEPACON	EQ 100MG BASE/ML	INJECTABLE / INJECTION	RLD	1996-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020593-001	DEPACON	EQ 100MG BASE/ML	INJECTABLE / INJECTION	RLD	1996-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020593-001	DEPACON	EQ 100MG BASE/ML	INJECTABLE / INJECTION	RLD	1996-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020593-001	DEPACON	EQ 100MG BASE/ML	INJECTABLE / INJECTION	RLD	1996-12-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020593-001	DEPACON	EQ 100MG BASE/ML	INJECTABLE / INJECTION	RLD	1996-12-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020593-001	DEPACON	EQ 100MG BASE/ML	INJECTABLE / INJECTION	RLD	1996-12-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020593-001	DEPACON	EQ 100MG BASE/ML	INJECTABLE / INJECTION	RLD	1996-12-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020593-001	DEPACON	EQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1996-12-30	`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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valproate Sodium	VALPROATE SODIUM	Sagent Pharmaceuticals	8d5fc1c1-d3c0-497e-971b-6c4dba9a3fad	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALPROATE SODIUM
Valproate Sodium	VALPROATE SODIUM	Fresenius Kabi USA, LLC	3dfb6da1-f66a-4618-9f74-d2d6c16c0b58	2024-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALPROATE SODIUM
Valproate Sodium	VALPROATE SODIUM	Fresenius Kabi USA, LLC	c572ece7-03d3-4c2a-aeb5-61f2023b28ea	2024-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALPROATE SODIUM
Valproate Sodium	VALPROATE SODIUM	Hikma Pharmaceuticals USA Inc.	bcf57b31-4811-4104-82b3-46fb91a53ee0	2023-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALPROATE SODIUM
Valproate Sodium	VALPROATE SODIUM	Hikma Pharmaceuticals USA Inc.	7a687b2f-246d-4736-a20c-92421c263268	2023-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALPROATE SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-1564	Depacon	Valproate Sodium	AbbVie Inc.	NDA	Current
0074-1564	Depacon	Valproate Sodium	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63196	SUPPL	2020-05-20
63161	SUPPL	2020-05-20
61065	SUPPL	2019-11-26
61060	SUPPL	2019-11-26
57784	SUPPL	2019-02-22
57764	SUPPL	2019-02-22
54090	SUPPL	2018-05-10
54069	SUPPL	2018-05-10
50002	SUPPL	2017-10-10
49981	SUPPL	2017-10-06
47505	SUPPL	2017-03-08
47482	SUPPL	2017-03-07
45843	SUPPL	2016-11-08
45814	SUPPL	2016-11-04
34923	SUPPL	2016-02-23
25275	SUPPL	2016-02-23
12808	SUPPL	2015-10-06
2827	SUPPL	2015-09-25
34922	SUPPL	2015-03-17
2826	SUPPL	2015-03-17
25272	SUPPL	2015-01-08
12806	SUPPL	2015-01-08
34920	SUPPL	2014-12-03
25271	SUPPL	2014-11-24
34921	SUPPL	2014-08-22
25274	SUPPL	2014-08-21
25270	SUPPL	2014-06-23
12803	SUPPL	2014-06-23
25273	SUPPL	2014-06-11
12807	SUPPL	2014-06-10
34918	SUPPL	2013-09-17
2825	SUPPL	2013-09-17
34919	SUPPL	2013-07-02
34917	SUPPL	2013-03-04
2824	SUPPL	2013-03-01
25269	SUPPL	2011-10-13
2823	SUPPL	2011-10-13
2822	SUPPL	2011-10-13
12804	SUPPL	2011-10-12
34916	SUPPL	2011-10-07
12805	SUPPL	2011-10-07
41459	SUPPL	2008-02-19
44060	ORIG	2008-02-01
2821	SUPPL	2006-10-23
12802	SUPPL	2006-10-18
25268	SUPPL	2006-01-20
34915	SUPPL	2006-01-13
2820	SUPPL	2004-06-02
12801	SUPPL	2002-01-24
2819	SUPPL	2002-01-24