Application 212876

Type: ANDA
Sponsor: SOMERSET THERAPS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	TABLET;ORAL	EQ 450MG BASE	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
A212876-001	VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB		2024-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212876-001	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.

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	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212876-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2024-06-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212876-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212876-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212876-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212876-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212876-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212876-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212876-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212876-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212876-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212876-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212876-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212876-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212876-001	AB	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212876-001	AB	1	`a50c72e98297…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR	Somerset Therapeutics, LLC	b856bfaf-ec6b-4171-81c4-b9b07f780084	2026-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALGANCICLOVIR HYDROCHLORIDE
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	NorthStar Rx LLC	1cc09039-dcd6-4721-abd4-411535ccf442	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALGANCICLOVIR HYDROCHLORIDE generic name: VALGANCICLOVIR HYDROCHLORIDE
Valganciclovir hydrochloride for Oral	VALGANCICLOVIR HYDROCHLORIDE	AvKARE	07eb5abf-2322-4fb9-e063-6394a90a2311	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALGANCICLOVIR HYDROCHLORIDE
Valganciclovir	VALGANCICLOVIR HYDROCHLORIDE	AvKARE	0d0bbc91-27f6-29bc-e063-6394a90a0027	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALGANCICLOVIR HYDROCHLORIDE
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	Aurobindo Pharma Limited	8d2ffc05-2fbc-41f8-8656-fbc0bfa7ad83	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALGANCICLOVIR HYDROCHLORIDE generic name: VALGANCICLOVIR HYDROCHLORIDE
Valcyte	VALGANCICLOVIR	H2-Pharma, LLC	4c517a39-2ded-4c5a-8d56-276853414b31	2025-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALGANCICLOVIR HYDROCHLORIDE
Valganciclovir hydrochloride	VALGANCICLOVIR HYDROCHLORIDE	Ajanta Pharma USA Inc.	178a014b-92c7-44a7-abb8-95d89a2feb8f	2025-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Valganciclovir hydrochloride generic name: VALGANCICLOVIR HYDROCHLORIDE
Valganciclovir	VALGANCICLOVIR HYDROCHLORIDE	Strides Pharma Science Limited	89a934f0-85a3-44c1-82e5-d09d1738e08d	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALGANCICLOVIR HYDROCHLORIDE
Valganciclovir hydrochloride for Oral	VALGANCICLOVIR HYDROCHLORIDE	Actavis Pharma, Inc.	92281301-5fb5-4eea-8766-4863e241c234	2025-06-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALGANCICLOVIR HYDROCHLORIDE
VALGANCICLOVIR	VALGANCICLOVIR HYDROCHLORIDE	NorthStar RxLLC	2e8a4d62-2098-4ffe-a154-e45cfdfe6c4c	2024-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALGANCICLOVIR HYDROCHLORIDE
VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR	Granules Pharmaceuticals Inc.	39452b74-161d-4525-a0f7-fe486f001513	2024-02-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VALGANCICLOVIR HYDROCHLORIDE
Valganciclovir	VALGANCICLOVIR HYDROCHLORIDE	Strides Pharma Science Limited	390691b2-3db0-4b9f-934f-120674726f14	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALGANCICLOVIR HYDROCHLORIDE
Valganciclovir	VALGANCICLOVIR HYDROCHLORIDE	American Health Packaging	0e30509f-add6-43c8-9e1d-e10c55a207e6	2023-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALGANCICLOVIR HYDROCHLORIDE
valganciclovir hydrochloride	VALGANCICLOVIR HYDROCHLORIDE	Dr. Reddy's Laboratories Inc	e30ae2b2-dad2-39ba-6bc7-400807791ab0	2022-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: valganciclovir hydrochloride generic name: VALGANCICLOVIR HYDROCHLORIDE
VALGANCICLOVIR	VALGANCICLOVIR HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	28703782-9f48-4866-a32d-1604da9dee6b	2022-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALGANCICLOVIR HYDROCHLORIDE
valganciclovir hydrochloride	VALGANCICLOVIR HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	614ff447-7e5f-4ea6-ba85-ec1f6497b360	2022-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: valganciclovir hydrochloride generic name: VALGANCICLOVIR HYDROCHLORIDE