Home Applications 022257 Application 022257
Type NDA
Sponsor HOFFMANN LA ROCHE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VALCYTE VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION;ORAL 50MG/ML Yes Yes
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 N022257-001 VALCYTE VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022257-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022257-001 8889109 2027-12-11 Drug product 2017-10-16 N022257-001 9642911 2027-12-11 Drug product 2017-06-02
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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022257-001 VALCYTE 50MG/ML FOR SOLUTION / ORAL AB RLD, RS 2009-08-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022257-001 8889109 2027-12-11 Drug product 2017-10-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022257-001 9642911 2027-12-11 Drug product 2017-06-02 782e0a99824c…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Valcyte VALGANCICLOVIR H2-Pharma, LLC 4c517a39-2ded-4c5a-8d56-276853414b31 2025-12-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022257 application number: NDA022257
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0004-0039 Valcyte valganciclovir hydrochloride Genentech, Inc. NDA Current 0004-0039 Valcyte valganciclovir hydrochloride Genentech, Inc. NDA Current 0004-0039 Valcyte valganciclovir hydrochloride Genentech, Inc. NDA Current 0004-0039 Valcyte valganciclovir hydrochloride Genentech, Inc. NDA Current 0004-0039 Valcyte valganciclovir hydrochloride Genentech, Inc. NDA Current 0004-0039 Valcyte valganciclovir hydrochloride Genentech, Inc. NDA Current 0004-0039 Valcyte valganciclovir hydrochloride Genentech, Inc. NDA Current