Application 078919

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 125MG VALPROIC ACID	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078919-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2009-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078919-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078919-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078919-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078919-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078919-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078919-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078919-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078919-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078919-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078919-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078919-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078919-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078919-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078919-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078919-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078919-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078919-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078919-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078919-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078919-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078919-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078919-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078919-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078919-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078919-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078919-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078919-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078919-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078919-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078919-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078919-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078919-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078919-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078919-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078919-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078919-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078919-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078919-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078919-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078919-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078919-001	AB	1	`cb3db0bc1861…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex Sodium	DIVALPROEX SODIUM	Cardinal Health 107, LLC	8e86a610-45ef-4be7-a3ab-f656f5b32706	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078919 application number: ANDA078919 ndc (product): 55154-4759
divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	ab8616a5-ea72-4df7-b095-54ea19ef6fba	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078919 application number: ANDA078919 ndc (product): 70518-1749
divalproex sodium	DIVALPROEX SODIUM	Zydus Pharmaceuticals USA Inc.	ed710c62-8ba6-4f19-b240-3ee73cd03d67	2026-04-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078919 application number: ANDA078919 ndc (product): 68382-106
divalproex sodium	DIVALPROEX SODIUM	ATLANTIC BIOLOGICALS CORP.	699a9722-27bd-4e90-819b-d4ecb99466c8	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078919 application number: ANDA078919 ndc (product): 17856-0109
Divalproex Sodium	DIVALPROEX SODIUM	American Health Packaging	2e4778d8-8798-4da1-bb33-1aa1414b5809	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078919 application number: ANDA078919 ndc (product): 68084-313
divalproex sodium	DIVALPROEX SODIUM	Zydus Lifesciences Limited	b0f33792-dd96-40cc-a28e-acdcdca2f4b8	2024-11-28		Exact identifier application applno (ANDA): 078919 application number: ANDA078919 ndc (product): 65841-639

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0109	divalproex sodium	divalproex sodium	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0109	divalproex sodium	divalproex sodium	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
50268-258	divalproex sodium	divalproex sodium	AvPAK	ANDA	Current
50268-258	divalproex sodium	divalproex sodium	AvPAK	ANDA	Current
55154-4759	DIVALPROEX SODIUM	DIVALPROEX SODIUM	Cardinal Health	ANDA	Current
55154-4759	DIVALPROEX SODIUM	DIVALPROEX SODIUM	Cardinal Health 107, LLC	ANDA	Current
55154-4759	DIVALPROEX SODIUM	DIVALPROEX SODIUM	Cardinal Health	ANDA	Current
65841-639	divalproex sodium	divalproex sodium	Zydus Lifesciences Limited	ANDA	Current
65841-639	divalproex sodium	divalproex sodium	Cadila Healthcare Limited	ANDA	Current
65841-639	divalproex sodium	divalproex sodium	Cadila Healthcare Limited	ANDA	Current
68084-313	divalproex sodium	divalproex sodium	American Health Packaging	ANDA	Current
68084-313	divalproex sodium	divalproex sodium	American Health Packaging	ANDA	Current
68084-313	Divalproex Sodium	Divalproex Sodium	American Health Packaging	ANDA	Current
68084-313	Divalproex Sodium	Divalproex Sodium	American Health Packaging	ANDA	Current
68084-313	Divalproex Sodium	Divalproex Sodium	American Health Packaging	ANDA	Current
68382-106	divalproex sodium	divalproex sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-106	divalproex sodium	divalproex sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-106	divalproex sodium	divalproex sodium	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-106	divalproex sodium	divalproex sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-106	divalproex sodium	divalproex sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-106	divalproex sodium	divalproex sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70518-1749	divalproex sodium	divalproex sodium	REMEDYREPACK INC.	ANDA	Current
70518-1749	divalproex sodium	divalproex sodium	REMEDYREPACK INC.	ANDA	Current
70518-1749	divalproex sodium	divalproex sodium	REMEDYREPACK INC.	ANDA	Current
70518-1749	divalproex sodium	divalproex sodium	REMEDYREPACK INC.	ANDA	Current
70518-2527	divalproex sodium	divalproex sodium	REMEDYREPACK INC.	ANDA	Current
70518-2527	divalproex sodium	divalproex sodium	REMEDYREPACK INC.	ANDA	Current
70518-2527	divalproex sodium	divalproex sodium	REMEDYREPACK INC.	ANDA	Current
70518-2527	divalproex sodium	divalproex sodium	REMEDYREPACK INC.	ANDA	Current