Home Applications 020487 Application 020487
Type NDA
Sponsor GLAXOSMITHKLINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VALTREX VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Yes No 002 VALTREX VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL EQ 1GM BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020487-001 VALTREX VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 N020487-002 VALTREX VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB RLD 1995-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2 of 3 · 88 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 2019-12-13 00:20 UTC 2019-12 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 23 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0173-0565 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0565 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0565 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0565 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0565 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0565 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0565 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0565 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0933 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0933 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0933 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0933 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0933 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0933 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0933 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 0173-0933 VALTREX valacyclovir hydrochloride GlaxoSmithKline LLC NDA Current 50090-0753 VALTREX valacyclovir hydrochloride A-S Medication Solutions NDA Current 55289-926 VALTREX valacyclovir hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 63629-3982 VALTREX valacyclovir hydrochloride Bryant Ranch Prepack NDA Current 67296-0200 VALTREX valacyclovir hydrochloride RedPharm Drug NDA Current 67296-0200 VALTREX valacyclovir hydrochloride RedPharm Drug NDA Current 70518-2039 VALTREX valacyclovir hydrochloride REMEDYREPACK INC. NDA Current 70518-2039 VALTREX valacyclovir hydrochloride REMEDYREPACK INC. NDA Current