FDA.reportPublic FDA data

Application 020550

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALTREXVALACYCLOVIR HYDROCHLORIDETablet; OralEQ 500MG BASENoNo
002VALTREXVALACYCLOVIR HYDROCHLORIDETABLET; ORALEQ 1GM BASENoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDESportpharm LLC458bb24a-4f97-4003-93cb-356906a432c92026-02-05Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDENorthwind Health Company, LLCf32d5f04-4198-82a5-e053-2995a90a18412026-01-01Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDENorthwind Health Company, LLCf98aea50-e4d9-c0cc-e053-6294a90a811c2026-01-01Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEProficient Rx LPfb875f07-e9a0-48eb-a8b0-16ea7bbae9ab2026-01-01Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
ValacyclovirVALACYCLOVIRYiling Pharmaceutical, Inc.f3ee4017-a4fc-475d-a49b-b39168ec59662025-12-29Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEAurobindo Pharma Limitedf5cfb61e-d971-4a9c-b9ef-4f3368fe02f52025-12-04Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
VALTREXVALACYCLOVIR HYDROCHLORIDEGlaxoSmithKline LLCf8e0d8f8-cb73-4206-a484-88f5c4fbd7192025-11-12Warnings, Adverse reactionsName fallback
brand name: VALTREX
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEAvPAK7f5fc62f-d043-db36-ce92-7adc4f7a79a52025-10-15Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEPreferred Pharmaceuticals Inc.82ddec27-79ac-40f4-afde-707f3940f8932025-07-31Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEMylan Institutional Inc.2f0ecd75-e4b4-4493-b7a4-1666fc555c702025-07-22Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDENuCare Pharmacuticals,Inc.552b806d-97d2-364d-e054-00144ff8d46c2025-05-28Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDENuCare Pharmaceuticals,Inc.802308ed-8c26-fed5-e053-2a91aa0a42b02025-04-24Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDENuCare Pharmaceuticals,Inc.82bac944-417a-0af7-e053-2a91aa0a86742025-03-17Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEPreferred Pharmaceuticals Inc.8422aeeb-0c3b-478d-82fb-ca051809db012025-02-03Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEAmerican Health Packaging23fb4162-2310-486c-ba9f-f7c94b793e562025-01-08Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDENuCare Pharmaceuticals,Inc.8022eb52-da04-eb0a-e053-2a91aa0a6f872024-12-02Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDENuCare Pharmaceuticals,Inc.e005139e-6f76-9b2f-e053-2a95a90ab0fb2024-11-08Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEBryant Ranch Prepack4619bcc6-0070-4f3b-9cf9-900f3e5f7b192024-08-28Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEAsclemed USA, Inc.1864bf8b-07a2-4b82-8592-bf8ad6f9f8f92024-07-11Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDENuCare Pharmaceuticals,Inc.883f643b-27f6-5a3e-e053-2995a90a8ff12024-06-14Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
25156SUPPL2004-06-29
20716SUPPL2004-06-14
25157SUPPL2003-09-09
34813SUPPL2003-08-29
25158SUPPL2003-08-15
12716SUPPL2003-04-25
12715SUPPL2003-04-25
12714SUPPL2003-04-25
2706SUPPL2003-04-18
12713SUPPL2003-04-01
2707SUPPL2002-09-09
20715SUPPL1997-09-26
52379ORIG1900-01-01
52378ORIG1900-01-01