Application 078979

Type: ANDA
Sponsor: DR REDDYS LABS LTD

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
A078979-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2009-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078979-001	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	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`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	A078979-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078979-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078979-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078979-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078979-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078979-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078979-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078979-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078979-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078979-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078979-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078979-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078979-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078979-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078979-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078979-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078979-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078979-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078979-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078979-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078979-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078979-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078979-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078979-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078979-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078979-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078979-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078979-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078979-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078979-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078979-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078979-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078979-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078979-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078979-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078979-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078979-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078979-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078979-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078979-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex sodium	DIVALPROEX SODIUM	Major Pharmaceuticals	4a0fa934-ec8c-460e-86eb-11281728fe85	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078979 application number: ANDA078979 ndc (product): 0904-6615
Divalproex sodium	DIVALPROEX SODIUM	Cardinal Health 107, LLC	0816a066-9ee3-4c23-944d-3539fc2c12bf	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078979 application number: ANDA078979 ndc (product): 55154-3552
Divalproex sodium	DIVALPROEX SODIUM	Dr. Reddy's Laboratories Ltd	f911748c-fb3a-fe1a-ab2a-4b40455e05ef	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078979 application number: ANDA078979 ndc (product): 55111-532
Divalproex sodium	DIVALPROEX SODIUM	NorthStar Rx LLC	589ae3a6-8b2e-d931-d36b-1937287ab5c0	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078979 application number: ANDA078979
Divalproex sodium	DIVALPROEX SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	388fd4bc-f12f-4e55-a1e7-72aa585519fa	2024-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078979 application number: ANDA078979 ndc (product): 0615-8237

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-1393	Divalproex sodium	Divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-1393	Divalproex sodium	Divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8237	Divalproex sodium	Divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8237	Divalproex sodium	Divalproex sodium	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8237	Divalproex sodium	Divalproex sodium	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0904-6615	Divalproex sodium	Divalproex sodium	Major Pharmaceuticals	ANDA	Current
0904-6615	Divalproex sodium	Divalproex sodium	Major Pharmaceuticals	ANDA	Current
0904-6615	Divalproex sodium	Divalproex sodium	Major Pharmaceuticals	ANDA	Current
0904-6615	Divalproex sodium	Divalproex sodium	Major Pharmaceuticals	ANDA	Current
55111-532	Divalproex sodium	Divalproex sodium	Dr. Reddy's Laboratories	ANDA	Current
55111-532	Divalproex sodium	Divalproex sodium	Dr. Reddy's Laboratories Ltd	ANDA	Current
55111-532	Divalproex sodium	Divalproex sodium	Dr. Reddy's Laboratories Ltd	ANDA	Current
55111-532	Divalproex sodium	Divalproex sodium	Dr. Reddy's Laboratories Ltd	ANDA	Current
55111-532	Divalproex sodium	Divalproex sodium	Dr. Reddy's Laboratories Ltd	ANDA	Current
55111-532	Divalproex sodium	Divalproex sodium	Dr. Reddy's Laboratories Ltd	ANDA	Current
55111-532	Divalproex sodium	Divalproex sodium	Dr. Reddy's Laboratories Ltd	ANDA	Current
55154-3552	Divalproex sodium	Divalproex sodium	Cardinal Health	ANDA	Current
63739-995	Divalproex sodium	Divalproex sodium	McKesson Corporation dba SKY Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31400	ORIG	2009-01-27