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 3 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
valacyclovir hydrochlorideVALACYCLOVIR HYDROCHLORIDEJubilant Cadista Pharmaceuticals Inc.3277c17e-f953-2b0a-fe0a-4f5d1aeace9d2023-08-30Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEProficient Rx LPc6328ed5-a3d3-4948-94be-b226271d03112022-05-02Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEProficient Rx LP268af320-810a-48de-9a08-9850be2878e32022-03-01Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDETIME CAP LABORATORIES, INC.c33a2a36-16d3-4a35-e053-2995a90af2402021-07-17Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEAsclemed USA, Inc.b99b8309-dd80-422a-9b17-f20386dc4d8d2020-10-24Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochlorideVALACYCLOVIR HYDROCHLORIDEProficient Rx LPefe37bd1-a236-43cc-828c-b57e8a704d672020-01-01Warnings, 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