FDA.reportPublic FDA data

Application 021337

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INVANZERTAPENEM SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 1GM BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-3843INVANZertapenem sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-3843INVANZertapenem sodiumMerck Sharp & Dohme LLCNDACurrent
0006-3843INVANZertapenem sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-3843INVANZertapenem sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-3843INVANZertapenem sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-3843INVANZertapenem sodiumMerck Sharp & Dohme Corp.NDACurrent
0006-3843INVANZertapenem sodiumMerck Sharp & Dohme Corp.NDACurrent
42023-221ERTAPENEMertapenem sodiumPar Pharmaceutical Inc.NDACurrent
42023-221ERTAPENEMertapenem sodiumPar Pharmaceutical Inc.NDACurrent
42023-221ERTAPENEMertapenem sodiumPar Pharmaceutical Inc.NDACurrent
42023-221ERTAPENEMertapenem sodiumPar Pharmaceutical Inc.NDACurrent
42023-221ERTAPENEMertapenem sodiumPar Pharmaceutical Inc.NDACurrent
42023-221ERTAPENEMertapenem sodiumPar Pharmaceutical Inc.NDACurrent
42023-221ERTAPENEMertapenem sodiumPar Pharmaceutical Inc.NDACurrent
42023-221ERTAPENEMertapenem sodiumPar Pharmaceutical Inc.NDACurrent
42023-221ERTAPENEMertapenem sodiumPar Pharmaceutical Inc.NDACurrent
42023-221ERTAPENEMertapenem sodiumPar Pharmaceutical Inc.NDACurrent
42023-221ERTAPENEMertapenem sodiumPar Pharmaceutical Inc.NDACurrent
42023-221ERTAPENEMertapenem sodiumPar Pharmaceutical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70564SUPPL2022-03-21
70555SUPPL2022-03-18
65754SUPPL2020-12-28
65714SUPPL2020-12-23
60172SUPPL2019-10-01
60089SUPPL2019-09-23
56939SUPPL2018-12-21
56895SUPPL2018-12-20
55524SUPPL2018-09-19
55480SUPPL2018-09-14
49809SUPPL2017-09-20
49727SUPPL2017-09-13
15216SUPPL2014-10-02
5081SUPPL2014-10-02
42107SUPPL2014-01-16
36689SUPPL2013-07-30
27515SUPPL2013-07-26
15215SUPPL2012-03-07
5080SUPPL2012-03-05
15214SUPPL2012-02-22
15211SUPPL2011-07-25
5078SUPPL2011-07-25
15213SUPPL2010-05-28
27514SUPPL2010-05-27
5077SUPPL2010-01-25
36688SUPPL2009-12-15
5079SUPPL2009-11-10
15212SUPPL2009-10-14
36687SUPPL2008-03-27
5076SUPPL2008-03-26
5075SUPPL2007-11-19
5074SUPPL2006-08-14
36686SUPPL2006-08-11
36685SUPPL2005-10-19
27513SUPPL2005-10-19
36684SUPPL2005-05-20
5073SUPPL2005-05-20
27512SUPPL2005-01-26
27511SUPPL2004-09-10
5072SUPPL2004-05-26
27510SUPPL2004-05-04
36683ORIG2001-11-09
21608ORIG2001-11-09
5071ORIG2001-11-09
51850ORIG1900-01-01
51849ORIG1900-01-01
51848ORIG1900-01-01
51847ORIG1900-01-01