FDA.reportPublic FDA data

Application 204990

Type
ANDA
Sponsor
LUPIN 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
68180-288Abacavir and LamivudineAbacavir and LamivudineLupin Pharmaceuticals, Inc.ANDACurrent
68180-288Abacavir and LamivudineAbacavir and LamivudineLupin Pharmaceuticals, Inc.ANDACurrent
68180-288Abacavir and LamivudineAbacavir and LamivudineLupin Pharmaceuticals, Inc.ANDACurrent
68180-288Abacavir and LamivudineAbacavir and LamivudineLupin Pharmaceuticals, Inc.ANDACurrent
68180-288Abacavir and LamivudineAbacavir and LamivudineLupin Pharmaceuticals, Inc.ANDACurrent
68180-288Abacavir and LamivudineAbacavir and LamivudineLupin Pharmaceuticals, Inc.ANDACurrent
70518-0715Abacavir and LamivudineAbacavir and LamivudineREMEDYREPACK INC.ANDACurrent
70518-0715Abacavir and LamivudineAbacavir and LamivudineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47791ORIG2017-03-30
45927ORIG2016-11-22