FDA.reportPublic FDA data

Application 213004

Type
NDA
Sponsor
REDHILL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TALICIAAMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTINCAPSULE, DELAYED RELEASE;ORAL250MG;EQ 10MG BASE;12.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57841-1150Taliciaomeprazole magnesium, amoxicillin and rifabutinRedHill Biopharma LtdNDACurrent
57841-1150Taliciaomeprazole magnesium, amoxicillin and rifabutinRedHill Biopharma LtdNDACurrent
57841-1150Taliciaomeprazole magnesium, amoxicillin and rifabutinRedHill Biopharma LtdNDACurrent
57841-1150Taliciaomeprazole magnesium, amoxicillin and rifabutinRedHill Biopharma LtdNDACurrent
57841-1150Taliciaomeprazole magnesium, amoxicillin and rifabutinRedHill Biopharma LtdNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78381SUPPL 2024-05-03
78358SUPPL 2024-05-02
75444SUPPL 2023-09-13
75388SUPPL 2023-09-11
74832SUPPL 2023-07-20
74787SUPPL 2023-07-19
70501SUPPL2022-03-14
70434SUPPL2022-03-07
68879SUPPL2021-10-05
68853SUPPL2021-10-01
65439SUPPL2020-12-01
65365SUPPL2020-11-30
62520ORIG2020-04-09
60788ORIG2019-11-07
60780ORIG2019-11-05