Application 070868

Type: ANDA
Sponsor: WOCKHARDT BIO AG

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
A070868-001	VALPROIC ACID	VALPROIC ACID	250MG/5ML	SYRUP / ORAL			1986-07-01

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	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL	AA	1986-07-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070868-001	VALPROIC ACID	250MG/5ML	SYRUP / ORAL		1986-07-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A070868-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070868-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070868-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070868-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070868-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070868-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070868-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070868-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070868-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070868-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070868-001	AA	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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valproic Acid	VALPROIC ACID	Xttrium Laboratories Inc.	3b124a29-30bd-d30e-e063-6294a90ac4ca	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070868 application number: ANDA070868

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3027	Valproic Acid	Valproic Acid	A-S Medication Solutions	ANDA	Current
55154-1575	Valproic Acid	Valproic Acid	Cardinal Health	ANDA	Current
60432-621	Valproic Acid	Valproic Acid	Morton Grove Pharmaceuticals, Inc.	ANDA	Current
60432-621	Valproic Acid	Valproic Acid	Morton Grove Pharmaceuticals, Inc.	ANDA	Current
60432-621	Valproic Acid	Valproic Acid	Morton Grove Pharmaceuticals, Inc.	ANDA	Current
60432-621	Valproic Acid	Valproic Acid	Morton Grove Pharmaceuticals, Inc.	ANDA	Current
60687-262	Valproic Acid	Valproic Acid	American Health Packaging	ANDA	Current
60687-262	Valproic Acid	Valproic Acid	American Health Packaging	ANDA	Current
60687-262	Valproic Acid	Valproic Acid	American Health Packaging	ANDA	Current
60687-262	Valproic Acid	Valproic Acid	American Health Packaging	ANDA	Current
68094-193	Valproic Acid	Valproic Acid	Precision Dose Inc.	ANDA	Current
68094-193	Valproic Acid	Valproic Acid	Precision Dose Inc.	ANDA	Current
68094-193	Valproic Acid	Valproic Acid	Precision Dose Inc.	ANDA	Current
68094-193	Valproic Acid	Valproic Acid	Precision Dose Inc.	ANDA	Current
68094-193	Valproic Acid	Valproic Acid	Precision Dose Inc.	ANDA	Current
68094-701	Valproic Acid	Valproic Acid	Precision Dose Inc.	ANDA	Current
68094-701	Valproic Acid	Valproic Acid	Precision Dose Inc.	ANDA	Current
68094-701	Valproic Acid	Valproic Acid	Precision Dose Inc.	ANDA	Current
68094-701	Valproic Acid	Valproic Acid	Precision Dose Inc.	ANDA	Current
68094-701	Valproic Acid	Valproic Acid	Precision Dose Inc.	ANDA	Current