Application 090161

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	TABLET, EXTENDED RELEASE;ORAL	EQ 250MG VALPROIC ACID	No	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
A090161-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2012-03-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090161-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090161-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2012-03-15	`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	A090161-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090161-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090161-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090161-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090161-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090161-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090161-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090161-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090161-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090161-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090161-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090161-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090161-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090161-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090161-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090161-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090161-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090161-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090161-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090161-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090161-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090161-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090161-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090161-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090161-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090161-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090161-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090161-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090161-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090161-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090161-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090161-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090161-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090161-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090161-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090161-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090161-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090161-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090161-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090161-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex Sodium	DIVALPROEX SODIUM	Major Pharmaceuticals	4ef6c5fd-42b2-4419-9b5a-e6d63571e3a0	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090161 application number: ANDA090161 ndc (product): 0904-6363
Divalproex Sodium	DIVALPROEX SODIUM	Dr. Reddy's Laboratories Ltd	2e35f833-1cf7-12eb-9567-7a191e32e138	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090161 application number: ANDA090161 ndc (product): 55111-533
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	74a9f020-f7a1-44e2-a452-f0e37bd3e077	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090161 application number: ANDA090161 ndc (product): 70518-1138
Divalproex Sodium	DIVALPROEX SODIUM	Coupler LLC	533245ba-7088-c929-e063-6294a90abe1d	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090161 application number: ANDA090161

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8329	Divalproex Sodium	Divalproex Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8329	Divalproex Sodium	Divalproex Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6363	Divalproex Sodium	Divalproex Sodium	Major Pharmaceuticals	ANDA	Current
0904-6363	Divalproex Sodium	Divalproex Sodium	Major Pharmaceuticals	ANDA	Current
0904-6363	Divalproex Sodium	Divalproex Sodium	Major Pharmaceuticals	ANDA	Current
48433-126	Divalproex Sodium	Divalproex Sodium	Safecor Health, LLC	ANDA	Current
48433-126	Divalproex Sodium	Divalproex Sodium	Safecor Health, LLC	ANDA	Current
50090-3156	Divalproex Sodium	Divalproex Sodium	A-S Medication Solutions	ANDA	Current
55111-533	Divalproex Sodium	Divalproex Sodium	Dr. Reddy's Laboratories Ltd	ANDA	Current
55111-533	Divalproex Sodium	Divalproex Sodium	Dr. Reddy's Laboratories Ltd	ANDA	Current
55111-533	Divalproex Sodium	Divalproex Sodium	Dr. Reddy's Laboratories Ltd	ANDA	Current
55111-533	Divalproex Sodium	Divalproex Sodium	Dr. Reddy's Laboratories Ltd	ANDA	Current
55111-533	Divalproex Sodium	Divalproex Sodium	Dr. Reddy's Laboratories	ANDA	Current
55111-533	Divalproex Sodium	Divalproex Sodium	Dr. Reddy's Laboratories Ltd	ANDA	Current
70518-0312	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0312	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0312	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0312	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0312	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1138	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1138	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1138	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1138	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1138	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current