Application 209286

Type: ANDA
Sponsor: LUPIN 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
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 42.

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
A209286-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2019-10-18
A209286-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2019-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209286-001	AB
A209286-002	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 2 · 80 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	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A209286-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209286-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209286-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209286-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209286-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209286-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209286-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209286-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209286-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209286-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209286-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209286-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209286-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209286-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209286-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209286-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209286-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209286-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209286-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209286-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209286-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209286-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209286-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209286-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209286-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209286-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209286-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209286-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209286-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209286-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209286-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209286-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209286-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209286-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209286-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209286-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209286-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209286-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209286-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209286-002	AB	1	`bb7c543d1eb4…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	aa386ae3-ceac-4e3b-8fb1-ced3107a4c54	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286 ndc (product): 70518-3183
Divalproex sodium	DIVALPROEX SODIUM	PD-Rx Pharmaceuticals, Inc.	392df14f-4d65-4be9-973b-1f0ce1013d8f	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286 ndc (product): 72789-286
Divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	6af40b06-0a92-454c-9277-80e89de27231	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286 ndc (product): 70518-3477
Divalproex sodium	DIVALPROEX SODIUM	Lupin Pharmaceuticals, Inc.	1f081c74-9f73-4ed9-9157-8d73d586a409	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286 ndc (product): 68180-260 ndc (product): 68180-261
Divalproex sodium	DIVALPROEX SODIUM	Preferred Pharmaceuticals, Inc.	83a77f60-ed58-4fa0-a584-e6a0c767d19d	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	0822300b-68c0-4e70-b1ba-8eb42cf373f7	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286 ndc (product): 71335-1883
Divalproex Sodium ER	DIVALPROEX SODIUM ER	Direct_Rx	f86f185b-4acb-43b5-e053-6394a90a681c	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286
Divalproex sodium	DIVALPROEX SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	319bbead-bec8-4bb7-9ecb-b2e161c44b8d	2024-09-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286 ndc (product): 0615-8376 ndc (product): 0615-8377

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
0615-8376	Divalproex sodium	Divalproex sodium	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8377	Divalproex sodium	Divalproex sodium	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
17856-0262	Divalproex sodium	Divalproex sodium	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
50090-5783	Divalproex sodium	Divalproex sodium	A-S Medication Solutions	ANDA	Current
68180-260	Divalproex sodium	Divalproex sodium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-260	Divalproex sodium	Divalproex sodium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-260	Divalproex sodium	Divalproex sodium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-261	Divalproex sodium	Divalproex sodium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-261	Divalproex sodium	Divalproex sodium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-261	Divalproex sodium	Divalproex sodium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68788-8085	Divalproex sodium	Divalproex sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-3183	Divalproex sodium	Divalproex sodium	REMEDYREPACK INC.	ANDA	Current
70518-3183	Divalproex sodium	Divalproex sodium	REMEDYREPACK INC.	ANDA	Current
70518-3477	Divalproex sodium	Divalproex sodium	REMEDYREPACK INC.	ANDA	Current
70518-3477	Divalproex sodium	Divalproex sodium	REMEDYREPACK INC.	ANDA	Current
71335-1883	Divalproex sodium	Divalproex sodium	Bryant Ranch Prepack	ANDA	Current
71335-1883	Divalproex sodium	Divalproex sodium	Bryant Ranch Prepack	ANDA	Current
72789-286	Divalproex sodium	Divalproex sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current