Application 074060

Type: ANDA
Sponsor: HIGH TECH PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALPROIC ACID	VALPROIC ACID	SYRUP;ORAL	250MG/5ML	No	No

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

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
A074060-001	VALPROIC ACID	VALPROIC ACID	250MG/5ML	SYRUP / ORAL			1995-01-13

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 · 43 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
2026-09-14 22:38:34	2026-08	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1995-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074060-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1995-01-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074060-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074060-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074060-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074060-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074060-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074060-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074060-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074060-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074060-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074060-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074060-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074060-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074060-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074060-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074060-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074060-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074060-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074060-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074060-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074060-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074060-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074060-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074060-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074060-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074060-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074060-001	AA	1	`cb3db0bc1861…`

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VALPROIC ACID	VALPROIC ACID	QUAGEN PHARMACEUTICALS LLC	531c0fc7-5e80-49a5-a9d1-0916ec45d52c	2024-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALPROIC ACID generic name: VALPROIC ACID
Valproic Acid	VALPROIC ACID	Aphena Pharma Solutions - Tennessee, LLC	3798f957-8b32-4ac0-8fd1-80283414c255	2017-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valproic Acid generic name: VALPROIC ACID
valproic acid	VALPROIC ACID	Aphena Pharma Solutions - Tennessee, LLC	3904177b-8a26-4356-9080-d2a2e3f468af	2017-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: valproic acid generic name: VALPROIC ACID

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0792	Valproic Acid	Valproic Acid	Atlantic Biologicals Corps	ANDA	Current
50383-792	Valproic acid	Valproic acid	Akorn	ANDA	Current
50383-792	Valproic acid	Valproic acid	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-792	Valproic acid	Valproic acid	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-792	Valproic acid	Valproic acid	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-792	Valproic acid	Valproic acid	Akorn	ANDA	Current
50383-792	Valproic acid	Valproic acid	Hi-Tech Pharmacal Co., Inc.	ANDA	Current