FDA.reportPublic FDA data

Application 021081

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LANTUSINSULIN GLARGINE RECOMBINANTINJECTABLE;INJECTION100 UNITS/MLYesYes
002LANTUS SOLOSTARINSULIN GLARGINE RECOMBINANTINJECTABLE;INJECTION300 UNITS/3ML (100 UNITS/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0088-2219Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-2219Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-2219Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-2219Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-2219Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-2219Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-2219Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-2219Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-2219Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-2220Lantusinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-2220Lantusinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-2220Lantusinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-2220Lantusinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-2220Lantusinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-2220Lantusinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-2220Lantusinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-2220Lantusinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-2220Lantusinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-5020Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-5020Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-5020Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-5020Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-5020Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-5020Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-5020Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-5020Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-5020Lantus Solostarinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-5021Lantusinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-5021Lantusinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-5021Lantusinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-5021Lantusinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-5021Lantusinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-5021Lantusinsulin glarginesanofi-aventis U.S. LLCNDACurrent
0088-5021Lantusinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-5021Lantusinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0088-5021Lantusinsulin glarginesanofi-aventis U.S. LLCBLACurrent
0955-1728Insulin Glargine Solostarinsulin glargineWinthrop U.S.BLACurrent
0955-1728Insulin Glargine Solostarinsulin glargineWinthrop U.S.BLACurrent
0955-1729Insulin Glargineinsulin glargineWinthrop U.S.BLACurrent
0955-1729Insulin Glargineinsulin glargineWinthrop U.S.BLACurrent
12854-432Insulin Glargine Solostarinsulin glargineSanofi-Aventis Deutschland GmbHBLACurrent
12854-433Insulin Glargineinsulin glargineSanofi-Aventis Deutschland GmbHBLACurrent
50090-0876Lantusinsulin glargineA-S Medication SolutionsNDACurrent
50090-0876Lantusinsulin glargineA-S Medication SolutionsBLACurrent
50090-1398Lantus Solostarinsulin glargineA-S Medication SolutionsNDACurrent
50090-1398Lantus Solostarinsulin glargineA-S Medication SolutionsBLACurrent
50090-4068Lantus Solostarinsulin glargineA-S Medication SolutionsBLACurrent
50090-6178Insulin Glargine Solostarinsulin glargineA-S Medication SolutionsBLACurrent
50090-6184Insulin Glargineinsulin glargineA-S Medication SolutionsBLACurrent
55045-3685Lantusinsulin glargineDispensing Solutions, Inc.NDACurrent
64725-2220Lantusinsulin glargineTYA PharmaceuticalsNDACurrent
70518-1390Lantus Solostarinsulin glargineREMEDYREPACK INC.BLACurrent
70518-1390Lantus Solostarinsulin glargineREMEDYREPACK INC.NDACurrent
70518-1865Lantusinsulin glargineREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74674SUPPL 2023-06-30
74673SUPPL 2023-06-30
74672SUPPL 2023-06-30
74671SUPPL 2023-06-30
71258SUPPL2022-06-08
71252SUPPL2022-06-08
62378APPL2020-03-31
60960SUPPL2020-03-23
60959SUPPL2020-03-23
60909SUPPL2020-03-23
60908SUPPL2020-03-23
58646SUPPL2020-03-23
58638SUPPL2020-03-23
57207SUPPL2020-03-23
56817SUPPL2020-03-23
56597SUPPL2020-03-23
41938SUPPL2020-03-23
41937SUPPL2020-03-23
41936ORIG2020-03-23
36040SUPPL2020-03-23
36039SUPPL2020-03-23
36038SUPPL2020-03-23
36037SUPPL2020-03-23
36036SUPPL2020-03-23
36035SUPPL2020-03-23
36034ORIG2020-03-23
26679SUPPL2020-03-23
26678SUPPL2020-03-23
26677SUPPL2020-03-23
26676SUPPL2020-03-23
26675SUPPL2020-03-23
26674SUPPL2020-03-23
26673SUPPL2020-03-23
26672SUPPL2020-03-23
26671ORIG2020-03-23
23624ORIG2020-03-23
21426SUPPL2020-03-23
14314SUPPL2020-03-23
14313SUPPL2020-03-23
14312SUPPL2020-03-23
14311SUPPL2020-03-23
4241SUPPL2020-03-23
4240SUPPL2020-03-23