Application 203511

Type: ANDA
Sponsor: DR REDDYS LABS LTD

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
A203511-001	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
A203511-001	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	A203511-001	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	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203511-001	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	A203511-001	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	A203511-001	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	A203511-001	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	A203511-001	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	A203511-001	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	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203511-001	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	A203511-001	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	A203511-001	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	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203511-001	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	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203511-001	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	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203511-001	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	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203511-001	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	A203511-001	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	A203511-001	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	A203511-001	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	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203511-001	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	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203511-001	VALGANCICLOVIR HYDROCHLORIDE	EQ 450MG BASE	TABLET / ORAL	AB	2014-11-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203511-001	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	A203511-001	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	A203511-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203511-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203511-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203511-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203511-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203511-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203511-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203511-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203511-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203511-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203511-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203511-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203511-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203511-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203511-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203511-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203511-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203511-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203511-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203511-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203511-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203511-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203511-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203511-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203511-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203511-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203511-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203511-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203511-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203511-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203511-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203511-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203511-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203511-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203511-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203511-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203511-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203511-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203511-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203511-001	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	American Health Packaging	4db6dd63-e56b-45a4-86b2-ee125a1854a0	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203511 application number: ANDA203511 ndc (product): 68084-965
Valganciclovir	VALGANCICLOVIR	Golden State Medical Supply, Inc.	79f39244-dd20-acb3-e053-2a91aa0a4aee	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203511 application number: ANDA203511 ndc (product): 60429-846
Valganciclovir	VALGANCICLOVIR	Dr. Reddy's Laboratories Limited	f37c0780-b953-46c2-d7d4-959fc2c3e571	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203511 application number: ANDA203511 ndc (product): 55111-762

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-765	Valganciclovir	Valganciclovir	NorthStar Rx LLC	ANDA	Current
16714-765	Valganciclovir	Valganciclovir	NorthStar Rx LLC	ANDA	Current
16714-765	Valganciclovir	Valganciclovir	NorthStar Rx LLC	ANDA	Current
16714-765	Valganciclovir	Valganciclovir	NorthStar Rx LLC	ANDA	Current
48433-124	Valganciclovir	Valganciclovir	Safecor Health, LLC	ANDA	Current
48433-124	Valganciclovir	Valganciclovir	Safecor Health, LLC	ANDA	Current
48433-124	Valganciclovir	Valganciclovir	Safecor Health, LLC	ANDA	Current
55111-762	Valganciclovir	Valganciclovir	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-762	Valganciclovir	Valganciclovir	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-762	Valganciclovir	Valganciclovir	Dr. Reddy's Laboratories Limited	ANDA	Current
60429-846	Valganciclovir	Valganciclovir	Golden State Medical Supply Inc.	ANDA	Current
60429-846	Valganciclovir	Valganciclovir	Golden State Medical Supply, Inc.	ANDA	Current
60429-846	Valganciclovir	Valganciclovir	Golden State Medical Supply, Inc.	ANDA	Current
60429-846	Valganciclovir	Valganciclovir	Golden State Medical Supply, Inc.	ANDA	Current
68084-965	Valganciclovir	Valganciclovir	American Health Packaging	ANDA	Current
68084-965	Valganciclovir	Valganciclovir	American Health Packaging	ANDA	Current
68084-965	Valganciclovir	Valganciclovir	American Health Packaging	ANDA	Current
68084-965	Valganciclovir	Valganciclovir	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32436	ORIG	2014-11-10