Application 200790

Type: ANDA
Sponsor: ENDO PHARMS INC

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
A200790-001	VALGANCICLOVIR HYDROCHLORIDE	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB		2014-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200790-001	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	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200790-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`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	A200790-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200790-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200790-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200790-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200790-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200790-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200790-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200790-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200790-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200790-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200790-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200790-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200790-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200790-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200790-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200790-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200790-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200790-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200790-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200790-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200790-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200790-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200790-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200790-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200790-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200790-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200790-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200790-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200790-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200790-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200790-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200790-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200790-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200790-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200790-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200790-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200790-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200790-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200790-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200790-001	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 HYDROCHLORIDE	AvKARE	0d0bbc91-27f6-29bc-e063-6394a90a0027	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200790 application number: ANDA200790
Valganciclovir	VALGANCICLOVIR HYDROCHLORIDE	Strides Pharma Science Limited	89a934f0-85a3-44c1-82e5-d09d1738e08d	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200790 application number: ANDA200790
Valganciclovir	VALGANCICLOVIR HYDROCHLORIDE	Strides Pharma Science Limited	390691b2-3db0-4b9f-934f-120674726f14	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200790 application number: ANDA200790 ndc (product): 64380-153

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-6330	Valganciclovir	Valganciclovir hydrochloride	Par Pharmaceutical	ANDA	Current
42291-875	Valganciclovir	Valganciclovir hydrochloride	AvKARE, Inc.	ANDA	Current
42291-875	Valganciclovir	Valganciclovir hydrochloride	AvKARE	ANDA	Current
63629-2288	Valganciclovir	Valganciclovir hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2288	Valganciclovir	Valganciclovir hydrochloride	Bryant Ranch Prepack	ANDA	Current
64380-153	Valganciclovir	Valganciclovir hydrochloride	Strides Pharma Science Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32057	ORIG	2014-11-10