FDA.reportPublic FDA data

Application 207768

Type
NDA
Sponsor
AYTU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TUZISTRA XRCHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREXSUSPENSION, EXTENDED RELEASE;ORALEQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69442-480TUZISTRA XRcodeine polistirex and chlorpheniramine polistirexVernalis Therapeutics, Inc.NDACurrent
69654-480TUZISTRA XRcodeine polistirex and chlorpheniramine polistirexAytu Bioscience, Inc.NDACurrent
69654-480TUZISTRA XRcodeine polistirex and chlorpheniramine polistirexAytu Bioscience, Inc.NDACurrent
69654-480TUZISTRA XRcodeine polistirex and chlorpheniramine polistirexAytu BioPharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84680SUPPL 2026-01-06
84537SUPPL 2025-12-23
84536SUPPL 2025-12-23
77017SUPPL 2023-12-19
76928SUPPL 2023-12-18
76927SUPPL 2023-12-18
54832SUPPL2018-07-06
54808SUPPL2018-07-06
54769SUPPL2018-07-05
49643SUPPL2017-08-31
49607SUPPL2017-08-30
46893SUPPL2017-01-18
46864SUPPL2017-01-13
44962ORIG2015-12-09
23039ORIG2015-12-09
19968ORIG2015-05-06
32860ORIG2015-05-05