Application 090062

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, DELAYED RELEASE;ORAL	EQ 125MG VALPROIC ACID	No	No
002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, DELAYED RELEASE;ORAL	EQ 250MG VALPROIC ACID	No	No
003	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, DELAYED RELEASE;ORAL	EQ 500MG VALPROIC ACID	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090062-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17
A090062-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17
A090062-003	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090062-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090062-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090062-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090062-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090062-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090062-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090062-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090062-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090062-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090062-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090062-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090062-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090062-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090062-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090062-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090062-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090062-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090062-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090062-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090062-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090062-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090062-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090062-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090062-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090062-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090062-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090062-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	2009-03-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090062-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090062-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090062-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090062-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090062-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090062-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090062-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090062-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090062-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090062-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090062-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090062-003	AB	1	`ea99ee380514…`

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 5 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
divalproex sodium	DIVALPROEX SODIUM	A-S Medication Solutions	ea5c5e3c-c23f-4ec0-b1ab-6b317f3d2f91	2025-11-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Mylan Institutional Inc.	b367d81d-4eca-4e28-b490-34be4c003561	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	1107f190-bef1-41cb-9393-8479b0a56040	2025-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	71296464-0c09-4ff2-beb3-377af77dc4cf	2025-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	fbaff0ae-431e-4e83-81c2-41eb4b18ee87	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	79e6dc26-a38b-4642-a216-1fa1213b919a	2025-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	df8f3825-a037-4343-859d-e59bca5f1e43	2025-09-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	Coupler LLC	3eee54a6-5b4c-330d-e063-6394a90a9f18	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	d67af03a-5261-4358-8787-2e729267ff7e	2025-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	47412563-ec3e-44fd-9f3f-c00b9b09033a	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	cd6fe37a-d26d-4ae8-a894-b44878e6bf8e	2025-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	0822300b-68c0-4e70-b1ba-8eb42cf373f7	2025-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	e4a815eb-ea20-482a-bb67-06ab34264515	2025-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	Proficient Rx LP	15ffe3d8-d483-4c45-adc4-1cc8a5b68d19	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	American Health Packaging	ca6bbec6-5631-4436-957e-fb8707e1683d	2025-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Coupler LLC	38f4f2fd-400b-ccc4-e063-6294a90a5f41	2025-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
divalproex sodium	DIVALPROEX SODIUM	ATLANTIC BIOLOGICALS CORP.	699a9722-27bd-4e90-819b-d4ecb99466c8	2025-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	ATLANTIC BIOLOGICALS CORP.	57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc	2025-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	8b3cb30a-8d81-4aa9-bdb4-19413ae5fedf	2025-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	American Health Packaging	2e4778d8-8798-4da1-bb33-1aa1414b5809	2025-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53808-0356	Divalproex Sodium	divalproex sodium	State of Florida DOH Central Pharmacy	ANDA	Current