FDA.reportPublic FDA data

Application 200063

Type
NDA
Sponsor
NALPROPION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CONTRAVEBUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL90MG;8MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-772Contravenaltrexone hydrochloride and bupropion hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-772Contravenaltrexone hydrochloride and bupropion hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-772Contravenaltrexone hydrochloride and bupropion hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-772Contravenaltrexone hydrochloride and bupropion hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-772Contravenaltrexone hydrochloride and bupropion hydrochloridePD-Rx Pharmaceuticals, Inc.NDACurrent
50090-2868CONTRAVEnaltrexone hydrochloride and bupropion hydrochlorideA-S Medication SolutionsNDACurrent
50090-2945Contravenaltrexone hydrochloride and bupropion hydrochlorideA-S Medication SolutionsNDACurrent
50090-2945Contravenaltrexone hydrochloride and bupropion hydrochlorideA-S Medication SolutionsNDACurrent
51267-890Contravenaltrexone hydrochloride and bupropion hydrochlorideNalpropion Pharmaceuticals LLCNDACurrent
51267-890Contravenaltrexone hydrochloride and bupropion hydrochlorideNalpropion Pharmaceuticals, Inc.NDACurrent
51267-890Contravenaltrexone hydrochloride and bupropion hydrochlorideNalpropion Pharmaceuticals LLCNDACurrent
51267-890Contravenaltrexone hydrochloride and bupropion hydrochlorideNalpropion Pharmaceuticals, Inc.NDACurrent
51267-890Contravenaltrexone hydrochloride and bupropion hydrochlorideNalpropion Pharmaceuticals LLCNDACurrent
51267-890Contravenaltrexone hydrochloride and bupropion hydrochlorideNalpropion Pharmaceuticals LLCNDACurrent
64764-890CONTRAVEnaltrexone hydrochloride and bupropion hydrochlorideTakeda Pharmaceuticals America, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84103SUPPL 2025-11-06
84102SUPPL 2025-11-06
84101SUPPL 2025-11-06
84090SUPPL 2025-11-06
84089SUPPL 2025-11-06
78439SUPPL 2024-05-08
78416SUPPL 2024-05-07
76712SUPPL 2023-12-01
76710SUPPL 2023-12-01
67089SUPPL2021-04-16
67088SUPPL2021-04-16
67087SUPPL2021-04-16
64204SUPPL2020-08-05
64203SUPPL2020-08-05
64198SUPPL2020-08-05
54665SUPPL2018-06-21
54664SUPPL2018-06-21
54605SUPPL2018-06-14
48291SUPPL2017-05-09
48253SUPPL2017-05-05
47555SUPPL2017-03-14
47531SUPPL2017-03-13
24382ORIG2014-11-12
22827ORIG2014-11-12
32005ORIG2014-09-16
40003ORIG2014-09-11