FDA.reportPublic FDA data

Application 079246

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABACAVIR SULFATE AND LAMIVUDINEABACAVIR SULFATE; LAMIVUDINETABLET;ORALEQ 600MG BASE;300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5382Abacavir and LamivudineAbacavir and LamivudineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5382Abacavir and LamivudineAbacavir and LamivudineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5382Abacavir and LamivudineAbacavir and LamivudineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5382Abacavir and LamivudineAbacavir and LamivudineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5382Abacavir and LamivudineAbacavir and LamivudineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5382Abacavir and LamivudineAbacavir and LamivudineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5382Abacavir and LamivudineAbacavir and LamivudineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5382Abacavir and LamivudineAbacavir and LamivudineTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-115Abacavir and LamivudineAbacavir and LamivudineAvKARE, Inc.ANDACurrent
42291-115Abacavir and LamivudineAbacavir and LamivudineAvKAREANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45595ORIG2016-10-06
45469ORIG2016-10-04