Acyclovir Buccal Tablet

Brand(s)
Sitavig
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Innocutis (2015-11-14)
Oldest Current Product
2014-03-20
License(s)
NDA
RxNORM
BUCCAL TABLET\ACYCLOVIR
FDAOB
BUCCAL\TABLET\ACYCLOVIR
SPL Active
BUCCAL\TABLET, DELAYED RELEASE\ACYCLOVIR
SPL Moiety
BUCCAL\TABLET, DELAYED RELEASE\ACYCLOVIR

product(s) by strength(s)

acyclovir 50 mg buccal tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1687120049SitavigNDAInnocutis2014-03-20ACYCLOVIRBUCCALTABLET, DELAYED RELEASENDA20379100f7425a-6236-47ff-a087-f28f8cdb1aec

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203791SITAVIGINNOCUTIS HOLDINGS LLC2013-04-12p8747896, TREATMENT OF HERPES LABIALIS, SUBSTANCE
p8791127, TREATMENT OF HERPES LABIALIS, SUBSTANCE
p8592434, TREATMENT OF HERPES LABIALIS, SUBSTANCE
NEW PRODUCT [2016-04-12]NDA203791_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203791_001RXACYCLOVIR (50MG)BUCCALTABLETTrue2013-04-12SITAVIG

patent(s)

#idexpiration dateapplication(s)
1p8592434 (view patent)2030-06-16NDA203791
2p8747896 (view patent)2027-06-03NDA203791
3p8791127 (view patent)2027-03-23NDA203791

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100f7425a-6236-47ff-a087-f28f8cdb1aec (view SPL)NDC 68712-049-02Sitavig (ACYCLOVIR) Buccal Tablets 50 mgprescriptionHuman PrescriptionInnocutisanalysis, label, manufacture, pack2015-11-145687120049

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII