daclatasvir Oral Tablet

Brand(s)
Daklinza
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E.R. Squibb & Sons, L.L.C. (2015-08-31)
Oldest Current Product
2014-11-24
License(s)
NDA, EXPORT ONLY
RxNORM
ORAL TABLET\DACLATASVIR
FDAOB
ORAL\TABLET\DACLATASVIR DIHYDROCHLORIDE
SPL Active
ORAL\TABLET\DACLATASVIR DIHYDROCHLORIDE
SPL Moiety
ORAL\TABLET\DACLATASVIR

product(s) by strength(s)

daclatasvir 30 mg oral tablet

export only product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1000870213EXPORT ONLYBristol-Myers Squibb Company2014-11-24DACLATASVIR DIHYDROCHLORIDEORALTABLETf111fb76-fd3f-4979-bb53-2ecffd98421a

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000030213DaklinzaNDAE.R. Squibb & Sons, L.L.C.2015-07-27DACLATASVIR DIHYDROCHLORIDEORALTABLETNDA2068439803a6ff-8a3e-4c64-b3d0-7825c7123bf2

daclatasvir 60 mg oral tablet

export only product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1000870215EXPORT ONLYBristol-Myers Squibb Company2014-11-24DACLATASVIR DIHYDROCHLORIDEORALTABLETf111fb76-fd3f-4979-bb53-2ecffd98421a

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000030215DaklinzaNDAE.R. Squibb & Sons, L.L.C.2015-07-27DACLATASVIR DIHYDROCHLORIDEORALTABLETNDA2068439803a6ff-8a3e-4c64-b3d0-7825c7123bf2

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206843DAKLINZABRISTOL-MYERS SQUIBB CO2015-07-24p8900566, METHOD OF INHIBITING HEPATITIS C VIRUS/ METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
p8329159
p8629171, METHOD OF INHIBITING HEPATITIS C VIRUS, SUBSTANCE
p8642025, METHOD OF INHIBITING HEPATITIS C VIRUS/ METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY, SUBSTANCE
NEW CHEMICAL ENTITY [2020-07-24]NDA206843_001, NDA206843_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206843_001RXDACLATASVIR DIHYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalse2015-07-24DAKLINZA
2NDA206843_002RXDACLATASVIR DIHYDROCHLORIDE (EQ 60MG BASE)ORALTABLETTrue2015-07-24DAKLINZA

patent(s)

#idexpiration dateapplication(s)
1p8329159 (view patent)2028-04-13NDA206843
2p8629171 (view patent)2031-06-13NDA206843
3p8642025 (view patent)2027-08-11NDA206843
4p8900566 (view patent)2027-08-08NDA206843

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
19803a6ff-8a3e-4c64-b3d0-7825c7123bf2 (view SPL)These highlights do not include all the information needed to use DAKLINZA safely and effectively. See full prescribing information for DAKLINZA. DAKLINZA (daclatasvir) tablets, for oral useInitial U.S. Approval: 2015prescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2015-08-312000030213, 000030215
2f111fb76-fd3f-4979-bb53-2ecffd98421a (view SPL)daclatasvir for exportprescriptionHuman PrescriptionBristol-Myers Squibb Company2015-03-161000870213, 000870215

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