FDA.report

Valacyclovir Hydrochloride

Product NDC
68071-2738
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090682
Marketing category
ANDA
Substance
VALACYCLOVIR HYDROCHLORIDE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
68071-2738-110 TABLET, FILM COATED in 1 BOTTLE (68071-2738-1) 2022-05-27NoHistorical
68071-2738-414 TABLET, FILM COATED in 1 BOTTLE (68071-2738-4) 2022-05-27NoHistorical
68071-2738-66 TABLET, FILM COATED in 1 BOTTLE (68071-2738-6) 2024-11-08NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995NuCare Pharmaceuticals,Inc.2024-11-08HUMAN PRESCRIPTION DRUG LABEL3