FDA.reportPublic FDA data

Application 021427

Type
NDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASEYesNo
002CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 30MG BASEYesNo
004CYMBALTADULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 60MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-3235CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3235CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3235CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3235CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3235CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3235CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3235CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3235CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3240CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3240CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3240CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3240CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3240CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3240CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3240CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3240CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3270CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3270CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3270CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3270CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3270CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3270CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3270CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3270CymbaltaDuloxetine hydrochlorideEli Lilly and CompanyNDACurrent
21695-145CymbaltaDuloxetine hydrochlorideRebel Distributors Corp.NDACurrent
21695-146CymbaltaDuloxetine hydrochlorideRebel Distributors Corp.NDACurrent
21695-657CymbaltaDuloxetine hydrochlorideRebel Distributors CorpNDACurrent
35356-843CymbaltaDuloxetine hydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
43353-303CymbaltaDuloxetine hydrochlorideAphena Pharma Solutions - Tennessee, LLCNDACurrent
49999-618CymbaltaDuloxetine hydrochlorideLake Erie Medical Surgical & Supply DBA Quality Care Products LLCNDACurrent
52959-892CymbaltaDuloxetine hydrochlorideH.J. Harkins Company, Inc.NDACurrent
55289-028CymbaltaDuloxetine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-028CymbaltaDuloxetine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-028CymbaltaDuloxetine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-028CymbaltaDuloxetine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-028CymbaltaDuloxetine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-028CymbaltaDuloxetine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-036CymbaltaDuloxetine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-036CymbaltaDuloxetine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-036CymbaltaDuloxetine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-036CymbaltaDuloxetine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-036CymbaltaDuloxetine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-036CymbaltaDuloxetine hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
68151-4679CymbaltaDuloxetine hydrochlorideCarilion Materials ManagementNDACurrent
68151-4727DuloxetineDuloxetine hydrochlorideCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68151-4734CymbaltaDuloxetine hydrochlorideCarilion Materials ManagementNDACurrent
70518-2099CymbaltaDuloxetine hydrochlorideREMEDYREPACK INC.NDACurrent
70518-2099CymbaltaDuloxetine hydrochlorideREMEDYREPACK INC.NDACurrent
70518-2099CymbaltaDuloxetine hydrochlorideREMEDYREPACK INC.NDACurrent
70518-2099CymbaltaDuloxetine hydrochlorideREMEDYREPACK INC.NDACurrent
70518-2100CymbaltaDuloxetine hydrochlorideREMEDYREPACK INC.NDACurrent
70518-2100CymbaltaDuloxetine hydrochlorideREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75257SUPPL 2023-08-22
75256SUPPL 2023-08-22
75152SUPPL 2023-08-21
75151SUPPL 2023-08-21
75150SUPPL 2023-08-21
68701SUPPL2021-09-21
68700SUPPL2021-09-21
68686SUPPL2021-09-21
64868SUPPL2020-10-07
64799SUPPL2020-10-02
62618SUPPL2020-04-21
62617SUPPL2020-04-21
62613SUPPL2020-04-21
60435SUPPL2019-10-09
60262SUPPL2019-10-07
60261SUPPL2019-10-07
50896SUPPL2017-12-27
50806SUPPL2017-12-21
46735SUPPL2017-01-10
46734SUPPL2017-01-10
46686SUPPL2017-01-06
45197SUPPL2016-09-02
45196SUPPL2016-09-02
5341SUPPL2015-06-22
15440SUPPL2015-06-19
36890SUPPL2014-12-03
36887SUPPL2014-12-03
27740SUPPL2014-11-28
5339SUPPL2014-11-28
36892SUPPL2014-10-21
36891SUPPL2014-10-21
27743SUPPL2014-10-21
5340SUPPL2014-10-21
15439SUPPL2014-07-28
27744SUPPL2014-07-21
36889SUPPL2012-10-22
15438SUPPL2012-10-22
5338SUPPL2012-10-22
5337SUPPL2012-10-22
36888SUPPL2012-08-30
36886SUPPL2012-08-30
27741SUPPL2012-08-28
27738SUPPL2012-08-28
21649SUPPL2012-05-09
42152SUPPL2011-10-10
42151SUPPL2011-10-10
27742SUPPL2011-09-07
15437SUPPL2011-09-07
27739SUPPL2011-04-15
15436SUPPL2011-04-15
5336SUPPL2011-03-08
36885SUPPL2011-03-07
5335SUPPL2009-11-27
36884SUPPL2009-11-23
51519SUPPL2009-11-02
51518SUPPL2009-09-22
27736SUPPL2009-03-24
5334SUPPL2009-03-24
5333SUPPL2009-03-24
36883SUPPL2009-03-20
15434SUPPL2009-03-20
15433SUPPL2009-03-20
15435SUPPL2009-02-04
27737SUPPL2009-02-03
36882SUPPL2007-12-03
15431SUPPL2007-12-03
5332SUPPL2007-12-03
5331SUPPL2007-12-03
27735SUPPL2007-08-07
15432SUPPL2007-08-03
27734SUPPL2007-03-06
5330SUPPL2007-03-06
5329SUPPL2007-03-06
36881SUPPL2007-02-26
15430SUPPL2007-02-26
15428SUPPL2007-02-26
15429SUPPL2006-09-21
51517SUPPL2006-06-23
5328SUPPL2006-06-14
23658ORIG2005-07-29
5327SUPPL2005-02-23
42150ORIG2004-10-08
15427ORIG2004-08-10
5326ORIG2004-08-10
63904ORIG1900-01-01
63903ORIG1900-01-01
63902ORIG1900-01-01
53532ORIG1900-01-01
52895ORIG1900-01-01
52443SUPPL1900-01-01
52441SUPPL1900-01-01
52439ORIG1900-01-01
52438ORIG1900-01-01