FDA.reportPublic FDA data

Application 200533

Type
NDA
Sponsor
COLLEGIUM PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NUCYNTA ERTAPENTADOL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 50MG BASEYesNo
002NUCYNTA ERTAPENTADOL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 100MG BASEYesNo
003NUCYNTA ERTAPENTADOL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 150MG BASEYesNo
004NUCYNTA ERTAPENTADOL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 200MG BASEYesNo
005NUCYNTA ERTAPENTADOL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 250MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24510-058Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-058Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-058Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-058Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-058Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-116Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-116Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-116Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-116Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-116Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-174Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-174Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-174Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-174Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-174Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-232Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-232Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-232Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-232Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-232Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-291Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-291Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-291Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-291Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
24510-291Nucyntatapentadol hydrochlorideCollegium Pharmaceutical, Inc.NDACurrent
50458-860Nucyntatapentadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-861Nucyntatapentadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-862Nucyntatapentadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-863Nucyntatapentadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-864Nucyntatapentadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
55700-555Nucyntatapentadol hydrochlorideLAKE ERIE MEDICAL DBA QUANDACurrent
55700-555Nucyntatapentadol hydrochlorideLAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLCNDACurrent
55700-565Nucyntatapentadol hydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
55700-796Nucyntatapentadol hydrochlorideQuality Care Products, LLCNDACurrent
55700-796Nucyntatapentadol hydrochlorideQuality Care Products, LLCNDACurrent
55700-796Nucyntatapentadol hydrochlorideQuality Care Products, LLCNDACurrent
55700-797Nucyntatapentadol hydrochlorideQuality Care Products, LLCNDACurrent
55700-797Nucyntatapentadol hydrochlorideQuality Care Products, LLCNDACurrent
55700-797Nucyntatapentadol hydrochlorideQuality Care Products, LLCNDACurrent
69865-240Nucyntatapentadol hydrochlorideDepo NF Sub, LLCNDACurrent
69865-245Nucyntatapentadol hydrochlorideDepo NF Sub, LLCNDACurrent
69865-250Nucyntatapentadol hydrochlorideDepo NF Sub, LLCNDACurrent
69865-260Nucyntatapentadol hydrochlorideDepo NF Sub, LLCNDACurrent
69865-265Nucyntatapentadol hydrochlorideDepo NF Sub, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84534SUPPL 2025-12-23
84525SUPPL 2025-12-23
80079SUPPL 2024-11-04
80078SUPPL 2024-11-04
78823SUPPL 2024-06-18
78822SUPPL 2024-06-18
78813SUPPL 2024-06-18
77070SUPPL 2023-12-19
76943SUPPL 2023-12-18
66627SUPPL2021-03-08
66626SUPPL2021-03-08
66570SUPPL2021-03-08
60393SUPPL2019-10-08
60392SUPPL2019-10-08
60378SUPPL2019-10-08
55693SUPPL2018-10-01
55692SUPPL2018-10-01
55590SUPPL2018-09-24
55589SUPPL2018-09-24
48583SUPPL2017-05-31
46411SUPPL2016-12-21
46328SUPPL2016-12-20
45456SUPPL2016-10-03
9827SUPPL2016-04-22
32030SUPPL2015-07-07
32029SUPPL2014-08-20
32028SUPPL2014-04-17
40024SUPPL2014-04-16
32027SUPPL2013-04-18
40023SUPPL2012-08-29
32025SUPPL2012-08-29
18962SUPPL2012-07-12
32026SUPPL2012-07-11
43346ORIG2012-04-12
24095ORIG2011-08-30
32024ORIG2011-08-29
18961ORIG2011-08-26