Application 205166

Type: ANDA
Sponsor: HETERO LABS LTD V

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
A205166-001	VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB		2016-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205166-001	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 · 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	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205166-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2016-03-18	`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	A205166-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205166-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205166-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205166-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205166-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205166-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205166-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205166-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205166-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205166-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205166-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205166-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205166-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205166-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205166-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205166-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205166-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205166-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205166-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205166-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205166-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205166-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205166-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205166-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205166-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205166-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205166-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205166-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205166-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205166-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205166-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205166-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205166-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205166-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205166-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205166-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205166-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205166-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205166-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205166-001	AB	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valganciclovir	VALGANCICLOVIR	Major Pharmaceuticals	6a6533fd-0579-4059-ba87-aa399829a8b0	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205166 application number: ANDA205166 ndc (product): 0904-6796
Valganciclovir	VALGANCICLOVIR	AvPAK	85177859-e0f5-6d83-17f3-29cae1db96c3	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205166 application number: ANDA205166 ndc (product): 50268-787
Valganciclovir	VALGANCICLOVIR	Camber Pharmaceuticals, Inc.	383e8810-b877-4a4f-abdf-c8c4c8e394f8	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205166 application number: ANDA205166 ndc (product): 31722-832

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6796	Valganciclovir	Valganciclovir	Major Pharmaceuticals	ANDA	Current
0904-6796	Valganciclovir	Valganciclovir	Major Pharmaceuticals	ANDA	Current
0904-6796	Valganciclovir	Valganciclovir	Major Pharmaceuticals	ANDA	Current
31722-832	Valganciclovir	Valganciclovir	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-832	Valganciclovir	Valganciclovir	Camber Pharmaceuticals, Inc.	ANDA	Current
50268-787	Valganciclovir	Valganciclovir	AvPAK	ANDA	Current
50268-787	Valganciclovir	Valganciclovir	AvPAK	ANDA	Current
50268-787	Valganciclovir	Valganciclovir	AvPAK	ANDA	Current
63739-076	Valganciclovir	Valganciclovir	McKesson Corporation DBA SKY Packaging	ANDA	Current
63739-076	Valganciclovir	Valganciclovir	McKesson Corporation DBA SKY Packaging	ANDA	Current