FDA.reportPublic FDA data

Application 203791

Type
NDA
Sponsor
EPI HLTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SITAVIGACYCLOVIRTABLET;BUCCAL50MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68712-049SitavigAcyclovirCipher Pharmaceuticals US LLCNDACurrent
71403-049SitavigAcyclovirEPI Health, IncNDACurrent
71403-049SitavigAcyclovirEPI Health, IncNDACurrent
71403-049SitavigAcyclovirEPI Health, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61390SUPPL2019-12-23
61351SUPPL2019-12-19
24449ORIG2014-01-07
22935ORIG2014-01-07
40327ORIG2013-04-16
32466ORIG2013-04-16