FDA.reportPublic FDA data

Application 022304

Type
NDA
Sponsor
COLLEGIUM PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NUCYNTATAPENTADOL HYDROCHLORIDETABLET;ORALEQ 50MG BASEYesNo
002NUCYNTATAPENTADOL HYDROCHLORIDETABLET;ORALEQ 75MG BASEYesNo
003NUCYNTATAPENTADOL HYDROCHLORIDETABLET;ORALEQ 100MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-069NUCYNTAtapentadol hydrochlorideRebel Distributors CorpNDACurrent
24510-050Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-050Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-050Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-075Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-075Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-075Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-100Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-100Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-100Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
35356-525NucyntaTapentadol hydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-593NUCYNTAtapentadol hydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-611NUCYNTAtapentadol hydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
50458-820NUCYNTAtapentadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-830NUCYNTAtapentadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-840NUCYNTAtapentadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
55700-606Nucyntatapentadol hydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
55700-792Nucyntatapentadol hydrochlorideQuality Care Products, LLCNDACurrent
69865-210Nucyntatapentadol hydrochlorideDepo NF Sub, LLCNDACurrent
69865-220Nucyntatapentadol hydrochlorideDepo NF Sub, LLCNDACurrent
69865-230Nucyntatapentadol hydrochlorideDepo NF Sub, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84532SUPPL 2025-12-31
84526SUPPL 2025-12-23
80075SUPPL 2024-11-04
78827SUPPL 2024-06-18
78826SUPPL 2024-06-18
78810SUPPL 2024-06-18
77032SUPPL 2023-12-19
76939SUPPL 2023-12-18
76237ORIG 2023-11-03
74694SUPPL 2023-07-06
74689SUPPL 2023-07-05
66631SUPPL2021-03-08
66630SUPPL2021-03-08
66559SUPPL2021-03-05
60388SUPPL2019-10-08
60384SUPPL2019-10-08
60383SUPPL2019-10-08
55773SUPPL2018-10-01
55772SUPPL2018-10-01
55771SUPPL2018-10-01
55685SUPPL2018-10-01
55684SUPPL2018-10-01
46624SUPPL2016-12-30
46340SUPPL2016-12-21
46331SUPPL2016-12-21
29557SUPPL2013-11-06
7206SUPPL2013-11-06
38537SUPPL2013-11-01
17218SUPPL2013-11-01
38536SUPPL2013-07-12
38535SUPPL2013-07-12
38534SUPPL2013-07-12
29556SUPPL2013-07-12
29555SUPPL2013-07-12
29554SUPPL2013-07-12
17217SUPPL2013-07-12
17216SUPPL2013-07-12
7205SUPPL2013-07-12
7204SUPPL2013-07-12
29553SUPPL2010-11-04
7203SUPPL2010-11-04
38533SUPPL2010-11-01
17215SUPPL2010-11-01
29552SUPPL2010-01-20
38532SUPPL2009-11-16
17214ORIG2009-02-04
29551ORIG2009-01-25
24278ORIG2009-01-25
21988ORIG2009-01-25