FDA.reportPublic FDA data

Application 214044

Type
NDA
Sponsor
ATHENA BIOSCIENCE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QDOLOTRAMADOL HYDROCHLORIDESOLUTION;ORAL5MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68134-402tramadol hydrochloridetramadol hydrochloridePalmetto Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
71511-301QDOLOtramadol hydrochlorideAthena Bioscience, LLCNDACurrent
71511-301QDOLOtramadol hydrochlorideAthena Bioscience, LLCNDACurrent
71511-301QDOLOtramadol hydrochlorideAthena Bioscience, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84632SUPPL 2026-01-05
84586SUPPL 2025-12-29
80087SUPPL 2024-11-04
77062SUPPL 2023-12-19
76978SUPPL 2023-12-19
76977SUPPL 2023-12-19
76465ORIG 2023-11-07
68618SUPPL2021-09-14
68602SUPPL2021-09-13
68080ORIG2021-07-14
66892ORIG2021-03-26
66891ORIG2021-03-26
66893ORIG2020-09-02
64484SUPPL2020-09-02