Application 075379

Type: ANDA
Sponsor: PHARM ASSOC

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	Yes

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
A075379-001	VALPROIC ACID	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075379-001	AA

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA		2000-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075379-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	RS	2000-12-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075379-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075379-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075379-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075379-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075379-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075379-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075379-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075379-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075379-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075379-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075379-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075379-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075379-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075379-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075379-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075379-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075379-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075379-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075379-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075379-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075379-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075379-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075379-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075379-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075379-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075379-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075379-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075379-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075379-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075379-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075379-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075379-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075379-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075379-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075379-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075379-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075379-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075379-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075379-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075379-001	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 1 · 5 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	Exact identifier application applno (ANDA): 075379 application number: ANDA075379
VALPROIC ACID	VALPROIC ACID	REMEDYREPACK INC.	65c1589e-c591-4b79-b75e-884c0d609ae8	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075379 application number: ANDA075379
VALPROIC ACID	VALPROIC ACID	Major Pharmaceuticals	a33f7657-ad0f-43e9-ba48-024746e6d08e	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075379 application number: ANDA075379
VALPROIC ACID	VALPROIC ACID	PAI Holdings, LLC dba PAI Pharma	7d5cb52e-37dd-4dfa-a6f4-09f9548846c6	2025-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075379 application number: ANDA075379 ndc (product): 0121-4675 ndc (product): 0121-1350 ndc (product): 0121-0675
VALPROIC ACID	VALPROIC ACID	Bryant Ranch Prepack	db53c5aa-d7a5-49ba-8227-c2d67ced23e2	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075379 application number: ANDA075379

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1350	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1350	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1350	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1350	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1350	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1350	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1350	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1350	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4675	VALPROIC ACID	VALPROIC ACID	Pharmaceutical Associates, Inc.	ANDA	Current
0527-5407	VALPROIC ACID	VALPROIC ACID	Lannett Company, Inc.	ANDA	Current
0527-5407	VALPROIC ACID	VALPROIC ACID	Lannett Company, Inc.	ANDA	Current
17856-0675	VALPROIC ACID	VALPROIC ACID	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0675	VALPROIC ACID	VALPROIC ACID	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0675	VALPROIC ACID	VALPROIC ACID	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
55154-9430	Valproic Acid	VALPROIC ACID	Cardinal Health	ANDA	Current
70518-1968	VALPROIC ACID	VALPROIC ACID	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8639	ORIG	2000-12-15