Application 078445

Type: ANDA
Sponsor: ANCHEN PHARMS

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 43.

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
A078445-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL			2009-02-26
A078445-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL			2009-08-04

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 · 86 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	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078445-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078445-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	2009-08-04	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A078445-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078445-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078445-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078445-002	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 7 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	Dr.Reddy's Laboratories Limited	15f8a5be-e269-2e07-60d9-1dd7bf5f5281	2018-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	ad5e8bd8-c923-40f0-a106-55620c4247d7	2018-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	b74adc5e-e92d-46a7-afdc-a6464a440bde	2018-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Divalproex Sodium generic name: DIVALPROEX SODIUM
Divalproex Sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	9cfdcb58-d6d7-43bb-b6e1-17172b143296	2018-02-16	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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10370-510	Divalproex Sodium	Divalproex Sodium	Par Pharmaceutical, Inc.	ANDA	Current
10370-510	Divalproex Sodium	Divalproex Sodium	Par Pharmaceutical, Inc.	ANDA	Current
10370-510	Divalproex Sodium	Divalproex Sodium	Par Pharmaceutical, Inc.	ANDA	Current
10370-511	Divalproex Sodium	Divalproex Sodium	Par Pharmaceutical, Inc.	ANDA	Current
10370-511	Divalproex Sodium	Divalproex Sodium	Par Pharmaceutical, Inc.	ANDA	Current
10370-511	Divalproex Sodium	Divalproex Sodium	Par Pharmaceutical, Inc.	ANDA	Current
43063-295	Divalproex Sodium	Divalproex Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-295	Divalproex Sodium	Divalproex Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-295	Divalproex Sodium	Divalproex Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-3913	Divalproex Sodium	Divalproex Sodium	A-S Medication Solutions	ANDA	Current
67046-143	Divalproex Sodium	Divalproex Sodium	Contract Pharmacy Services-PA	ANDA	Current
70518-1498	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1498	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2497	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current