FDA.reportPublic FDA data

Application 204417

Type
NDA
Sponsor
SPARC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELEPSIA XRLEVETIRACETAMTABLET, EXTENDED RELEASE;ORAL1GMYesNo
002ELEPSIA XRLEVETIRACETAMTABLET, EXTENDED RELEASE;ORAL1.5GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47133-574Elepsia XRLevetiracetamSun Pharma Advanced Research Company LimitedNDACurrent
47133-574Elepsia XRLevetiracetamSun Pharma Advanced Research Company LimitedNDACurrent
47133-574Elepsia XRLevetiracetamSun Pharma Advanced Research Company LimitedNDACurrent
47133-574Elepsia XRLevetiracetamSun Pharma Advanced Research Company LimitedNDACurrent
47133-575Elepsia XRLevetiracetamSun Pharma Advanced Research Company LimitedNDACurrent
47133-575Elepsia XRLevetiracetamSun Pharma Advanced Research Company LimitedNDACurrent
47133-575Elepsia XRLevetiracetamSun Pharma Advanced Research Company LimitedNDACurrent
47133-575Elepsia XRLevetiracetamSun Pharma Advanced Research Company LimitedNDACurrent
80705-100ELEPSIA XR 1000 MGlevetiracetamTRIPOINT THERAPEUTICS, LLCNDACurrent
80705-100ELEPSIA XR 1000 MGlevetiracetamTRIPOINT THERAPEUTICS, LLCNDACurrent
80705-101ELEPSIA XR 1500 MGlevetiracetamTRIPOINT THERAPEUTICS, LLCNDACurrent
80705-101ELEPSIA XR 1500 MGlevetiracetamTRIPOINT THERAPEUTICS, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77814SUPPL 2024-03-13
77800SUPPL 2024-03-13
77799SUPPL 2024-03-13
65654SUPPL2020-12-21
65618SUPPL2020-12-17
65617SUPPL2020-12-17
58162ORIG2019-04-01
56978ORIG2018-12-21
56977ORIG2018-12-21