Application 077567

Type: ANDA
Sponsor: MYLAN

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
A077567-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2009-01-29
A077567-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2009-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077567-001	AB
A077567-002	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 · 84 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	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A077567-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077567-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077567-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077567-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077567-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077567-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077567-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077567-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077567-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077567-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077567-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077567-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077567-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077567-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077567-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077567-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077567-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077567-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077567-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077567-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077567-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077567-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077567-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077567-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077567-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077567-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077567-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077567-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077567-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077567-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077567-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077567-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077567-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077567-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077567-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077567-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077567-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077567-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077567-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077567-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex Sodium	DIVALPROEX SODIUM	Mylan Pharmaceuticals Inc.	00332c65-edad-a153-9c78-628931daa732	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077567 application number: ANDA077567 ndc (product): 0378-0472 ndc (product): 0378-0473
Divalproex Sodium	DIVALPROEX SODIUM	Safecor Health, LLC	3aec1944-86a1-490c-a734-d9dd3b52c9d6	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077567 application number: ANDA077567
Divalproex Sodium	DIVALPROEX SODIUM	Mylan Institutional Inc.	b367d81d-4eca-4e28-b490-34be4c003561	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077567 application number: ANDA077567 ndc (product): 51079-767 ndc (product): 51079-766
Divalproex Sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	bf34dd25-abe3-4587-b481-df052f085429	2023-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077567 application number: ANDA077567 ndc (product): 71610-030
Divalproex Sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	0f5bb45e-836b-48ce-9764-2d50edcb202c	2023-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077567 application number: ANDA077567

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-7554	Divalproex Sodium	divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7555	Divalproex Sodium	divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7555	Divalproex Sodium	divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7555	Divalproex Sodium	divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8242	Divalproex Sodium	divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8242	Divalproex Sodium	divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43353-547	Divalproex Sodium	divalproex sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-547	Divalproex Sodium	divalproex sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-766	Divalproex Sodium	divalproex sodium	Mylan Institutional Inc.	ANDA	Current
51079-766	Divalproex Sodium	divalproex sodium	Mylan Institutional Inc.	ANDA	Current
51079-766	Divalproex Sodium	divalproex sodium	Mylan Institutional Inc.	ANDA	Current
51079-767	Divalproex Sodium	divalproex sodium	Mylan Institutional Inc.	ANDA	Current
51079-767	Divalproex Sodium	divalproex sodium	Mylan Institutional Inc.	ANDA	Current
51079-767	Divalproex Sodium	divalproex sodium	Mylan Institutional Inc.	ANDA	Current
53808-0831	Divalproex Sodium	divalproex sodium	State of Florida DOH Central Pharmacy	ANDA	Current
55154-4381	Divalproex Sodium	divalproex sodium	Cardinal Health	ANDA	Current
67046-122	Divalproex Sodium	divalproex sodium	Contract Pharmacy Services-PA	ANDA	Current
71610-030	Divalproex Sodium	divalproex sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18466	ORIG	2009-02-24
31263	ORIG	2009-02-03