Application 078239

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	TABLET, EXTENDED RELEASE;ORAL	EQ 250MG VALPROIC ACID	No	No
002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, EXTENDED RELEASE;ORAL	EQ 500MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078239-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2009-02-27
A078239-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2009-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078239-001	AB
A078239-002	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 3 · 82 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	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078239-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078239-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078239-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078239-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078239-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078239-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078239-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078239-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078239-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078239-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078239-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078239-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078239-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078239-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078239-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078239-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078239-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078239-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078239-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078239-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078239-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078239-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078239-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078239-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078239-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078239-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078239-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078239-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078239-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078239-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078239-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078239-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078239-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078239-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078239-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078239-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078239-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078239-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078239-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078239-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex Sodium	DIVALPROEX SODIUM	American Health Packaging	a8ba3986-1ded-44a8-8d10-d0f252a07794	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078239 application number: ANDA078239 ndc (product): 68084-310 ndc (product): 68084-415
Divalproex Sodium	DIVALPROEX SODIUM	BluePoint Laboratories	1b12c694-e120-45f6-ad28-36373e2c5378	2025-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078239 application number: ANDA078239 ndc (product): 68001-105 ndc (product): 68001-106

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65841-637	Divalproex Sodium	Divalproex Sodium	Cadila Healthcare Limited	ANDA	Current
65841-637	Divalproex Sodium	Divalproex Sodium	Cadila Healthcare Limited	ANDA	Current
65841-637	Divalproex Sodium	Divalproex Sodium	Cadila Healthcare Limited	ANDA	Current
65841-637	Divalproex Sodium	Divalproex Sodium	Zydus Lifesciences Limited	ANDA	Current
65841-638	Divalproex Sodium	Divalproex Sodium	Cadila Healthcare Limited	ANDA	Current
65841-638	Divalproex Sodium	Divalproex Sodium	Cadila Healthcare Limited	ANDA	Current
65841-638	Divalproex Sodium	Divalproex Sodium	Cadila Healthcare Limited	ANDA	Current
65841-638	Divalproex Sodium	Divalproex Sodium	Zydus Lifesciences Limited	ANDA	Current
68001-105	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-105	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-105	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-105	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-105	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-105	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-105	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-106	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-106	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-106	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-106	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-106	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-106	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-106	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68084-310	Divalproex Sodium	Divalproex Sodium	American Health Packaging	ANDA	Current
68084-310	Divalproex Sodium	Divalproex Sodium	American Health Packaging	ANDA	Current
68084-310	Divalproex Sodium	Divalproex Sodium	American Health Packaging	ANDA	Current
68084-310	Divalproex Sodium	Divalproex Sodium	American Health Packaging	ANDA	Current
68084-415	Divalproex Sodium	Divalproex Sodium	American Health Packaging	ANDA	Current
68084-415	Divalproex Sodium	Divalproex Sodium	American Health Packaging	ANDA	Current
68084-415	Divalproex Sodium	Divalproex Sodium	American Health Packaging	ANDA	Current
68084-415	Divalproex Sodium	Divalproex Sodium	American Health Packaging	ANDA	Current
68382-133	Divalproex Sodium	Divalproex Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-133	Divalproex Sodium	Divalproex Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-133	Divalproex Sodium	Divalproex Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-133	Divalproex Sodium	Divalproex Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-133	Divalproex Sodium	Divalproex Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-134	Divalproex Sodium	Divalproex Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-134	Divalproex Sodium	Divalproex Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-134	Divalproex Sodium	Divalproex Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-134	Divalproex Sodium	Divalproex Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-134	Divalproex Sodium	Divalproex Sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70518-2033	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current