FDA.reportPublic FDA data

Application 021572

Type
NDA
Sponsor
CUBIST PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CUBICINDAPTOMYCINPOWDER;INTRAVENOUS250MG/VIALNoNo
002CUBICINDAPTOMYCINPOWDER;INTRAVENOUS500MG/VIALYesYes
003CUBICIN RFDAPTOMYCINPOWDER;INTRAVENOUS500MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-0125DaptomycinDaptomycinTeva Parenteral Medicines, Inc.NDA AUTHORIZED GENERICCurrent
0703-0125DaptomycinDaptomycinTeva Parenteral Medicines, Inc.NDA AUTHORIZED GENERICCurrent
0703-0125DaptomycinDaptomycinTeva Parenteral Medicines, Inc.NDA AUTHORIZED GENERICCurrent
0703-0125DaptomycinDaptomycinTeva Parenteral Medicines, Inc.NDA AUTHORIZED GENERICCurrent
0703-0125DaptomycinDaptomycinTeva Parenteral Medicines, Inc.NDA AUTHORIZED GENERICCurrent
0703-0125DaptomycinDaptomycinTeva Parenteral Medicines, Inc.NDA AUTHORIZED GENERICCurrent
0703-0125DaptomycinDaptomycinTeva Parenteral Medicines, Inc.NDA AUTHORIZED GENERICCurrent
67919-011CubicinDaptomycinMerck Sharp & Dohme Corp.NDACurrent
67919-011CubicinDaptomycinMerck Sharp & Dohme LLCNDACurrent
67919-011CubicinDaptomycinMerck Sharp & Dohme LLCNDACurrent
67919-011CubicinDaptomycinMerck Sharp & Dohme Corp.NDACurrent
67919-011CubicinDaptomycinMerck Sharp & Dohme Corp.NDACurrent
67919-011CubicinDaptomycinMerck Sharp & Dohme Corp.NDACurrent
67919-011CubicinDaptomycinMerck Sharp & Dohme Corp.NDACurrent
67919-011CubicinDaptomycinMerck Sharp & Dohme Corp.NDACurrent
67919-012CUBICIN RFDaptomycinMerck Sharp & Dohme Corp.NDACurrent
67919-012CUBICIN RFDaptomycinMerck Sharp & Dohme Corp.NDACurrent
67919-012CUBICIN RFDaptomycinMerck Sharp & Dohme Corp.NDACurrent
67919-012CUBICIN RFDaptomycinMerck Sharp & Dohme Corp.NDACurrent
67919-012CUBICIN RFDaptomycinMerck Sharp & Dohme LLCNDACurrent
67919-012CUBICIN RFDaptomycinMerck Sharp & Dohme LLCNDACurrent
67919-012CUBICIN RFDaptomycinMerck Sharp & Dohme LLCNDACurrent
67919-012CUBICIN RFDaptomycinMerck Sharp & Dohme Corp.NDACurrent
67919-012CUBICIN RFDaptomycinMerck Sharp & Dohme Corp.NDACurrent
67919-012CUBICIN RFDaptomycinMerck Sharp & Dohme LLCNDACurrent
67919-012CUBICIN RFDaptomycinMerck Sharp & Dohme LLCNDACurrent
67919-012CUBICIN RFDaptomycinMerck Sharp & Dohme Corp.NDACurrent
67919-012CUBICIN RFDaptomycinMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82206SUPPL 2025-05-21
82195SUPPL 2025-05-15
82177SUPPL 2025-05-14
82205SUPPL 2025-05-12
74717SUPPL 2023-07-11
70253SUPPL2022-02-25
70240SUPPL2022-02-24
69142SUPPL2021-10-27
69141SUPPL2021-10-27
69134SUPPL2021-10-27
69133SUPPL2021-10-27
64464SUPPL2020-09-01
64463SUPPL2020-09-01
64427SUPPL2020-08-27
64426SUPPL2020-08-27
56654SUPPL2018-12-07
56624SUPPL2018-12-04
51736SUPPL2018-01-25
49677SUPPL2017-09-06
49676SUPPL2017-09-06
49664SUPPL2017-09-05
49663SUPPL2017-09-05
48701SUPPL2017-06-12
48695SUPPL2017-06-12
47832SUPPL2017-04-03
47831SUPPL2017-04-03
47790SUPPL2017-03-30
47789SUPPL2017-03-30
45789SUPPL2016-11-02
45788SUPPL2016-11-02
37265SUPPL2016-07-18
28157SUPPL2016-07-12
37264SUPPL2016-07-08
37263SUPPL2015-12-03
5768SUPPL2015-09-18
5767SUPPL2015-08-06
15806SUPPL2015-08-04
37262SUPPL2014-12-19
5766SUPPL2014-11-28
37261SUPPL2013-11-26
37260SUPPL2013-11-26
28156SUPPL2013-11-26
5765SUPPL2013-11-26
5764SUPPL2012-10-15
15805SUPPL2012-10-12
37259SUPPL2012-06-18
28155SUPPL2012-06-15
28154SUPPL2012-05-23
15803SUPPL2012-05-23
5763SUPPL2011-10-04
15804SUPPL2011-10-03
28152SUPPL2010-12-10
28153SUPPL2010-12-06
28151SUPPL2010-12-06
28150SUPPL2010-12-06
28149SUPPL2010-12-06
28148SUPPL2010-12-06
5762SUPPL2010-12-06
37258SUPPL2010-12-02
37257SUPPL2010-12-02
37256SUPPL2010-12-02
37255SUPPL2010-12-02
15801SUPPL2010-12-02
15800SUPPL2010-12-02
15802SUPPL2010-08-28
5761SUPPL2009-02-13
37254SUPPL2007-10-10
5760SUPPL2007-10-10
37253SUPPL2007-08-22
5757SUPPL2007-08-22
28147SUPPL2007-02-23
5759SUPPL2007-02-23
15799SUPPL2007-02-21
15798SUPPL2007-02-21
28146SUPPL2006-11-06
15797SUPPL2006-10-25
15796SUPPL2006-05-26
5758SUPPL2006-05-26
37252SUPPL2005-10-19
28145SUPPL2005-10-19
21740ORIG2003-12-15
37251ORIG2003-09-25
5756ORIG2003-09-25
62935SUPPL1900-01-01
62934SUPPL1900-01-01
62933SUPPL1900-01-01
62930SUPPL1900-01-01
52894SUPPL1900-01-01
52892SUPPL1900-01-01
52593SUPPL1900-01-01
52592SUPPL1900-01-01