Application 073229

Type: ANDA
Sponsor: CATALENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALPROIC ACID	VALPROIC ACID	CAPSULE;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A073229-001	VALPROIC ACID	VALPROIC ACID	250MG	CAPSULE / ORAL	AB		1991-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073229-001	AB

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 · 42 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
2026-08-18 06:07:40	2026-07	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073229-001	VALPROIC ACID	250MG	CAPSULE / ORAL	AB	1991-10-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A073229-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073229-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073229-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073229-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073229-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073229-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073229-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073229-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073229-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073229-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073229-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073229-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073229-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073229-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073229-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073229-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073229-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073229-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073229-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073229-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073229-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073229-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073229-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073229-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073229-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073229-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073229-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073229-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073229-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073229-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073229-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073229-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073229-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073229-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073229-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073229-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073229-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073229-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073229-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073229-001	AB	1	`e64feba35796…`

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	VALPROIC ACID	Actavis Pharma, Inc.	cef3e335-5891-412f-89c4-79fcd2f145b7	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073229 application number: ANDA073229 ndc (product): 0591-4012
valproic acid	VALPROIC ACID	Upsher-Smith Laboratories, LLC	7d4df6ad-3d53-4664-9200-749487bf3689	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073229 application number: ANDA073229 ndc (product): 0832-0310
Valproic	VALPROIC ACID	Aphena Pharma Solutions - Tennessee, LLC	34a0d45a-4388-7d8b-e063-6394a90a6c3f	2025-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073229 application number: ANDA073229
Valproic Acid	VALPROIC ACID	Direct_Rx	8bdbacb1-b38a-3282-e053-2a95a90af022	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073229 application number: ANDA073229 ndc (product): 72189-010
valproic acid	VALPROIC ACID	Aphena Pharma Solutions - Tennessee, LLC	3904177b-8a26-4356-9080-d2a2e3f468af	2017-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073229 application number: ANDA073229 ndc (product): 43353-085

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-4012	Valproic	Valproic Acid	Actavis Pharma, Inc.	ANDA	Current
0591-4012	Valproic	Valproic Acid	Actavis Pharma, Inc.	ANDA	Current
0591-4012	Valproic	Valproic Acid	Actavis Pharma, Inc.	ANDA	Current
0591-4012	Valproic	Valproic Acid	Actavis Pharma, Inc.	ANDA	Current
0591-4012	Valproic	Valproic Acid	Actavis Pharma, Inc.	ANDA	Current
0591-4012	Valproic	Valproic Acid	Actavis Pharma, Inc.	ANDA	Current
0591-4012	Valproic	Valproic Acid	Actavis Pharma, Inc.	ANDA	Current
0615-1325	Valproic Acid	Valproic Acid	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7840	Valproic	Valproic Acid	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0832-0310	valproic acid	valproic acid	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0310	valproic acid	valproic acid	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0310	valproic acid	valproic acid	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0310	valproic acid	valproic acid	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0310	valproic acid	valproic acid	Upsher-Smith Laboratories, LLC	ANDA	Current
17856-4012	Valproic	Valproic Acid	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
42291-844	Valproic	Valproic Acid	AvKARE, Inc.	ANDA	Current
42291-844	Valproic	Valproic Acid	AvKARE	ANDA	Current
43353-085	valproic acid	valproic acid	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-107	Valproic	Valproic Acid	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
63629-7597	Valproic	Valproic Acid	Bryant Ranch Prepack	ANDA	Current
63629-7597	Valproic	Valproic Acid	Bryant Ranch Prepack	ANDA	Current
63629-7597	Valproic	Valproic Acid	Bryant Ranch Prepack	ANDA	Current
63739-086	valproic acid	valproic acid	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-086	valproic acid	valproic acid	McKesson Corporation dba SKY Packaging	ANDA	Current
67046-806	Valproic	Valproic Acid	Contract Pharmacy Services-PA	ANDA	Current
67544-479	Valproic Acid	valproic acid	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68071-2702	Valproic Acid	valproic acid	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-0730	valproic acid	valproic acid	REMEDYREPACK INC.	ANDA	Current
70518-0730	valproic acid	valproic acid	REMEDYREPACK INC.	ANDA	Current
70518-0730	valproic acid	valproic acid	REMEDYREPACK INC.	ANDA	Current
70518-0730	valproic acid	valproic acid	REMEDYREPACK INC.	ANDA	Current
70518-2215	Valproic	Valproic Acid	REMEDYREPACK INC.	ANDA	Current
72189-010	Valproic Acid	Valproic Acid	Direct_Rx	ANDA	Current
72189-010	Valproic Acid	Valproic Acid	Direct_Rx	ANDA	Current