Application 077960

Type: ANDA
Sponsor: LANNETT CO INC

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 1.

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
A077960-001	VALPROIC ACID	VALPROIC ACID	250MG/5ML	SYRUP / ORAL			2006-10-13

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		2006-10-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077960-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	2006-10-13	`cb3db0bc1861…`

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	A077960-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077960-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077960-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077960-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077960-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077960-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077960-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077960-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077960-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077960-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077960-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077960-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077960-001	AA	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077960-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077960-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077960-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077960-001	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 1 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VALPROIC ACID	VALPROIC ACID	American Health Packaging	4b619f73-44e5-4a99-b425-a96cb2228c87	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALPROIC ACID generic name: VALPROIC ACID
VALPROIC ACID	VALPROIC ACID	REMEDYREPACK INC.	65c1589e-c591-4b79-b75e-884c0d609ae8	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALPROIC ACID generic name: VALPROIC ACID
Valproic	VALPROIC ACID	Actavis Pharma, Inc.	cef3e335-5891-412f-89c4-79fcd2f145b7	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALPROIC ACID
Valproic Acid	VALPROIC ACID	Bionpharma Inc.	ceb52870-76d0-4108-a1d4-ba7096fbacdd	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valproic Acid generic name: VALPROIC ACID
Valproic Acid	VALPROIC ACID	Chartwell RX, LLC	8051ad62-3b6e-461e-8090-60f5c0a904f4	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valproic Acid generic name: VALPROIC ACID
Valproic Acid	VALPROIC ACID	REMEDYREPACK INC.	ec41025a-ed7d-48c8-9005-08e3a9417f30	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valproic Acid generic name: VALPROIC ACID
Valproic Acid	VALPROIC ACID	Xttrium Laboratories Inc.	3b124a29-30bd-d30e-e063-6294a90ac4ca	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valproic Acid generic name: VALPROIC ACID
Valproic Acid	VALPROIC ACID	ANI Pharmaceuticals, Inc.	2314af65-b928-42a9-91eb-6372909ab4f5	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valproic Acid generic name: VALPROIC ACID
Valproic Acid	VALPROIC ACID	Chartwell Governmental & Specialty RX, LLC.	5d19f389-7180-4e01-845f-519b7ea60ba0	2025-11-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valproic Acid generic name: VALPROIC ACID
VALPROIC ACID	VALPROIC ACID	Major Pharmaceuticals	a33f7657-ad0f-43e9-ba48-024746e6d08e	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALPROIC ACID generic name: VALPROIC ACID
Valproic Acid	VALPROIC ACID	REMEDYREPACK INC.	1edd220d-d151-4177-9a29-9fee36489fb7	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valproic Acid generic name: VALPROIC ACID
Valproic Acid	VALPROIC ACID	Kesin Pharma Corporation	3a2155d0-e79d-3e11-e063-6294a90a4aae	2025-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valproic Acid generic name: VALPROIC ACID
valproic acid	VALPROIC ACID	Upsher-Smith Laboratories, LLC	7d4df6ad-3d53-4664-9200-749487bf3689	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: valproic acid generic name: VALPROIC ACID
Valproic Acid	VALPROIC ACID	ATLANTIC BIOLOGICALS CORP.	453444b6-1f50-49de-ab3c-1e429c83bffa	2025-06-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valproic Acid generic name: VALPROIC ACID
Valproic Acid	VALPROIC ACID	NCS HealthCare of KY, LLC dba Vangard Labs	8785a152-3010-4370-aaf5-11315a1a56e1	2025-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valproic Acid generic name: VALPROIC ACID
Valproic	VALPROIC ACID	Aphena Pharma Solutions - Tennessee, LLC	34a0d45a-4388-7d8b-e063-6394a90a6c3f	2025-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALPROIC ACID
VALPROIC ACID	VALPROIC ACID	PAI Holdings, LLC dba PAI Pharma	7d5cb52e-37dd-4dfa-a6f4-09f9548846c6	2025-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALPROIC ACID generic name: VALPROIC ACID
Valproic Acid	VALPROIC ACID	Bryant Ranch Prepack	a9cef1ec-ba52-4849-8889-87898d6f4199	2025-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valproic Acid generic name: VALPROIC ACID
Valproic Acid	VALPROIC ACID	Direct_Rx	8bdbacb1-b38a-3282-e053-2a95a90af022	2025-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valproic Acid generic name: VALPROIC ACID
VALPROIC ACID	VALPROIC ACID	Bryant Ranch Prepack	db53c5aa-d7a5-49ba-8227-c2d67ced23e2	2024-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALPROIC ACID generic name: VALPROIC ACID

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-5250	VALPROIC ACID	VALPROIC ACID	Lannett Company, Inc.	ANDA	Current
0527-5250	VALPROIC ACID	VALPROIC ACID	Lannett Company, Inc.	ANDA	Current
0527-5250	VALPROIC ACID	VALPROIC ACID	Lannett Company, Inc.	ANDA	Current
0527-5250	VALPROIC ACID	VALPROIC ACID	Lannett Company, Inc.	ANDA	Current
0527-5250	VALPROIC ACID	VALPROIC ACID	Lannett Company, Inc.	ANDA	Current
0603-1841	Valproic Acid	Valproic Acid	Par Pharmaceutical	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9100	ORIG	2006-10-18