Application 078869

Type: ANDA
Sponsor: VIWIT PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	250MG	No	No
002	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	500MG	No	No
003	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	750MG	No	No
004	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	1GM	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078869-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-13
A078869-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-13
A078869-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-13
A078869-004	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-03-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078869-001	AB
A078869-002	AB
A078869-003	AB
A078869-004	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 5 · 168 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	A078869-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078869-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078869-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078869-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078869-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078869-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078869-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078869-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078869-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078869-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078869-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078869-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078869-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078869-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078869-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078869-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078869-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078869-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078869-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078869-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078869-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078869-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078869-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078869-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078869-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078869-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078869-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078869-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078869-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078869-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078869-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078869-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078869-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078869-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078869-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078869-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078869-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078869-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078869-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078869-004	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2009-03-13	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A078869-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078869-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078869-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078869-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078869-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078869-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078869-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078869-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078869-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078869-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078869-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078869-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078869-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078869-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078869-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078869-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078869-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078869-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078869-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078869-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078869-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078869-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078869-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078869-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078869-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078869-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078869-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078869-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078869-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078869-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078869-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078869-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078869-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078869-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078869-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078869-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078869-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078869-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078869-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078869-004	AB	1	`d8e5a09893c0…`

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 9 · 167 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVETIRACETAM	LEVETIRACETAM	REMEDYREPACK INC.	17969eda-4c85-40a0-9a94-7e4675adf910	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Ascend Laboratories, LLC	591dd9f1-3681-4b2f-b096-7536826e3648	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Cardinal Health 107, LLC	e1b14939-7262-40dc-a334-2b3b72c88d47	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	a1b28234-1f7c-40bf-80a7-6cc98b3839fe	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Micro Labs Limited	1e3cfafe-5784-4ec6-91dc-cd74b01d0bb4	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam Levetiracetam	LEVETIRACETAM	Atlantic Biologicals Corp.	56fed03f-38c3-4273-8fd7-522bc508bf36	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Cardinal Health 107, LLC	a91defd2-486b-4995-ba4c-640525ab575d	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	dfc218c5-672a-420a-b59e-2e0b054e99ad	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	ae405796-1eca-4890-bcb2-e1b07654a24d	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Bryant Ranch Prepack	ace53552-d616-45e8-9f99-2f0041d0b430	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Coupler LLC	266d4ead-fda2-f030-e063-6394a90a68e2	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	1c26c0ad-9d37-45c5-9091-849509f4fc01	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	90e01877-abcb-4697-a7ed-9afe5ee77050	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Unit Dose Solutions, Inc.	551626eb-3282-e439-e063-6294a90a8314	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Direct_Rx	5517b148-1eff-6421-e063-6394a90a9498	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Bryant Ranch Prepack	bb6e1c75-66eb-4d18-af70-9b51fb67c4d6	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	a05bbfa4-c34f-4134-8207-db79e4c70445	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	23073db5-3fc4-4051-a22d-e49a63e42647	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	94d042f7-93b9-43bd-9ace-cfc61903b4d7	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	74ccc9f1-b957-4b1b-9464-1b5e3318c916	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM