FDA.reportPublic FDA data

Application 021652

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPZICOMABACAVIR SULFATE; LAMIVUDINETABLET;ORALEQ 600MG BASE;300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49349-701EpzicomAbacavir Sulfate and LamivudineREMEDYREPACK INC.NDACurrent
49702-206EPZICOMabacavir sulfate and lamivudineViiV Healthcare CompanyNDACurrent
49702-206EPZICOMabacavir sulfate and lamivudineViiV Healthcare CompanyNDACurrent
49702-206EPZICOMabacavir sulfate and lamivudineViiV Healthcare CompanyNDACurrent
49702-206EPZICOMabacavir sulfate and lamivudineViiV Healthcare CompanyNDACurrent
49702-206EPZICOMabacavir sulfate and lamivudineViiV Healthcare CompanyNDACurrent
49702-206EPZICOMabacavir sulfate and lamivudineViiV Healthcare CompanyNDACurrent
49702-206EPZICOMabacavir sulfate and lamivudineViiV Healthcare CompanyNDACurrent
49702-206EPZICOMabacavir sulfate and lamivudineViiV Healthcare CompanyNDACurrent
50090-0874EPZICOMabacavir sulfate and lamivudineA-S Medication SolutionsNDACurrent
53808-0767EPZICOMabacavir sulfate and lamivudineState of Florida DOH Central PharmacyNDACurrent
66993-482Abacavir and Lamivudineabacavir sulfate and lamivudinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-482Abacavir and Lamivudineabacavir sulfate and lamivudinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
70518-0691EPZICOMabacavir sulfate and lamivudineREMEDYREPACK INC.NDACurrent
70518-0691EPZICOMabacavir sulfate and lamivudineREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69574SUPPL2021-12-15
69555SUPPL2021-12-15
69554SUPPL2021-12-15
66285SUPPL2021-02-18
66279SUPPL2021-02-18
66278SUPPL2021-02-18
58723SUPPL2019-05-15
58703SUPPL2019-05-14
54038SUPPL2018-05-08
54037SUPPL2018-05-08
53919SUPPL2018-05-01
47689SUPPL2017-03-24
47614SUPPL2017-03-21
15923SUPPL2015-10-07
5919SUPPL2015-10-01
5918SUPPL2015-09-18
28314SUPPL2015-02-24
37403SUPPL2015-02-20
37402SUPPL2012-05-22
5917SUPPL2012-05-22
5916SUPPL2012-03-13
15922SUPPL2012-03-12
37401SUPPL2011-11-29
5915SUPPL2011-11-22
5914SUPPL2011-05-17
5912SUPPL2011-02-07
37400SUPPL2011-02-04
5913SUPPL2010-08-10
37399SUPPL2009-03-26
5911SUPPL2009-03-11
37398SUPPL2007-05-09
28313SUPPL2007-05-09
42252ORIG2006-10-25
5910SUPPL2006-08-18
15921SUPPL2006-08-14
37397ORIG2004-08-05
28312ORIG2004-08-05
51094SUPPL1900-01-01
51093SUPPL1900-01-01
51092SUPPL1900-01-01