FDA.reportPublic FDA data

Application 090159

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
35573-430Abacavir and LamivudineAbacavir and LamivudineBurel Pharmaceuticals, Inc.ANDACurrent
35573-430Abacavir and LamivudineAbacavir and LamivudineBurel Pharmaceuticals, LLCANDACurrent
35573-430Abacavir and LamivudineAbacavir and LamivudineBurel PharmaANDACurrent
35573-430Abacavir and LamivudineAbacavir and LamivudineBurel Pharmaceuticals, Inc.ANDACurrent
65862-335Abacavir and LamivudineAbacavir and LamivudineAurobindo Pharma LimitedANDACurrent
65862-335Abacavir and LamivudineAbacavir and LamivudineAurobindo Pharma LimitedANDACurrent
65862-335Abacavir and LamivudineAbacavir and LamivudineAurobindo Pharma LimitedANDACurrent
65862-335Abacavir and LamivudineAbacavir and LamivudineAurobindo Pharma LimitedANDACurrent
65862-335Abacavir and LamivudineAbacavir and LamivudineAurobindo Pharma LimitedANDACurrent
65862-335Abacavir and LamivudineAbacavir and LamivudineAurobindo Pharma LimitedANDACurrent