FDA.reportPublic FDA data

Application 021995

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JANUVIASITAGLIPTIN PHOSPHATETABLET;ORALEQ 25MG BASEYesNo
002JANUVIASITAGLIPTIN PHOSPHATETABLET;ORALEQ 50MG BASEYesNo
003JANUVIASITAGLIPTIN PHOSPHATETABLET;ORALEQ 100MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0112JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0112JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0112JANUVIAsitagliptinMerck Sharp & Dohme LLCNDACurrent
0006-0112JANUVIAsitagliptinMerck Sharp & Dohme LLCNDACurrent
0006-0112JANUVIAsitagliptinMerck Sharp & Dohme LLCNDACurrent
0006-0112JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0112JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0112JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0112JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0221JANUVIAsitagliptinMerck Sharp & Dohme LLCNDACurrent
0006-0221JANUVIAsitagliptinMerck Sharp & Dohme LLCNDACurrent
0006-0221JANUVIAsitagliptinMerck Sharp & Dohme LLCNDACurrent
0006-0221JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0221JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0221JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0221JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0221JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0221JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0277JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0277JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0277JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0277JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0277JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0277JANUVIAsitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-0277JANUVIAsitagliptinMerck Sharp & Dohme LLCNDACurrent
0006-0277JANUVIAsitagliptinMerck Sharp & Dohme LLCNDACurrent
0006-0277JANUVIAsitagliptinMerck Sharp & Dohme LLCNDACurrent
50090-3472JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
50090-3472JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
50090-3472JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
50090-3527JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
50090-3527JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
50090-4084JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
50090-4084JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
50090-4086JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
50090-4086JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
50090-4087JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
50090-5517JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
50090-5517JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
50090-5547JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
50090-5585JANUVIAsitagliptinA-S Medication SolutionsNDACurrent
55154-5040JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5040JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5040JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5040JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5040JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5040JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5040JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5040JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5042JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5042JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5042JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5042JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5042JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5042JANUVIAsitagliptinCardinal HealthNDACurrent
55154-5044JANUVIAsitagliptinCardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77283SUPPL 2024-01-23
71442SUPPL2022-06-24
71441SUPPL2022-06-24
71425SUPPL2022-06-22
65548SUPPL2020-12-09
65520SUPPL2020-12-08
65503SUPPL2020-12-04
59691SUPPL2019-08-13
59687SUPPL2019-08-13
59681SUPPL2019-08-13
59279SUPPL2019-07-09
59278SUPPL2019-07-09
59207SUPPL2019-07-02
52633SUPPL2018-02-14
52560SUPPL2018-02-12
52554SUPPL2018-02-12
49405SUPPL2017-08-15
49348SUPPL2017-08-14
46948SUPPL2017-01-24
46918SUPPL2017-01-18
38043SUPPL2015-09-04
29022SUPPL2015-09-01
38042SUPPL2015-05-04
6636SUPPL2015-04-29
38041SUPPL2015-03-12
29021SUPPL2015-03-12
42375SUPPL2015-03-11
21898SUPPL2015-03-11
38039SUPPL2013-10-22
6635SUPPL2013-08-22
38040SUPPL2013-08-21
44166ORIG2013-04-29
38038SUPPL2013-02-08
6634SUPPL2013-02-08
29020SUPPL2012-10-22
16722SUPPL2012-10-22
16721SUPPL2012-03-27
6633SUPPL2012-03-27
16720SUPPL2012-02-27
29018SUPPL2011-06-17
6632SUPPL2011-04-19
16719SUPPL2011-04-18
38037SUPPL2010-09-29
29019SUPPL2010-09-29
29017SUPPL2010-09-29
16718SUPPL2010-09-29
29016SUPPL2010-03-05
29015SUPPL2010-03-05
6631SUPPL2010-03-05
6629SUPPL2010-03-05
38035SUPPL2010-03-02
38034SUPPL2010-03-02
16717SUPPL2010-03-02
16716SUPPL2010-03-02
6630SUPPL2010-01-14
38036SUPPL2010-01-12
29014SUPPL2008-10-23
38033SUPPL2008-07-23
29013SUPPL2008-07-23
29012SUPPL2007-10-22
29011SUPPL2007-10-22
29010SUPPL2007-10-22
6628SUPPL2007-10-22
42374ORIG2006-12-13
6627ORIG2006-10-23
38032ORIG2006-10-18