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 1 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDECardinal Health 107, LLC72300f70-57fd-42a8-a2dc-4cf95a1ce8052026-08-13Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.de96c14b-cd74-46dd-bcce-d1fa640a60372026-08-06Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDERedpharm Drug57e5cc11-f3cb-6266-e063-6394a90afc472026-07-31Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f2026-07-22Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
VALTREXVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.56a62c21-bead-4f3b-a24e-c3fd0b4a732f2026-07-16Warnings, Adverse reactionsName fallback
brand name: VALTREX
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.1ecd2332-4c60-46c1-a175-774926ffc6c62026-06-26Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEBryant Ranch Prepacka56f37e1-dcc2-4fb1-ae39-bb20b9b7a3d32026-06-16Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEBryant Ranch Prepackc28c069f-3b51-4474-aa38-1aed6b7b86782026-06-12Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDESt. Mary's Medical Park Pharmacy275c0198-10a5-139e-e063-6394a90a72be2026-06-04Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEBryant Ranch Prepack93dccd99-d28b-4c47-872c-c3c0001b8a7f2026-06-04Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a888812-2867-4dd3-b56e-2d98da837d1f2026-05-12Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDENorthStar Rx LLC4acf51de-26f7-42b2-8acc-61b800627ef32026-05-12Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDESportpharm LLC7681a6f4-a6e7-4277-adbd-38837d5ead6b2026-04-24Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEA-S Medication Solutions8c0be4f6-2d11-41d4-8f57-4f8db9da60b22026-03-24Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEMajor Pharmaceuticalsfd982aee-d503-47b3-8d3d-42e9a86904572026-03-24Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEA-S Medication Solutions87ec59e3-c06a-4ca7-bc65-5b251263ab3b2026-03-17Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEA-S Medication Solutionsdf34e11d-5f2c-4755-b84b-b95d1d7b73f02026-03-17Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDERising Pharma Holdings, Inc.8d1645c0-fd03-4992-9372-98026a26b3af2026-03-10Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ae8d15a4-1ed5-4e3c-9672-0f4735322a1c2026-02-25Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e300970d-1145-4460-a8c8-f6e1654c2c3d2026-02-25Warnings, 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