FDA.reportPublic FDA data

Application 050420

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIFADINRIFAMPINCAPSULE;ORAL300MGYesYes
002RIFADINRIFAMPINCAPSULE;ORAL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84407SUPPL 2025-12-15
84371SUPPL 2025-12-09
83706SUPPL 2025-10-09
83699SUPPL 2025-10-09
79872SUPPL 2024-10-11
79863SUPPL 2024-10-11
76766SUPPL 2023-12-12
76758SUPPL 2023-12-11
75121SUPPL 2023-08-18
75104SUPPL 2023-08-17
73581SUPPL 2023-02-21
73572SUPPL 2023-02-21
73495SUPPL 2023-02-14
73458SUPPL 2023-02-13
70049SUPPL2022-02-02
70000SUPPL2022-01-31
69077SUPPL2021-10-22
69066SUPPL2021-10-21
67872SUPPL2021-06-23
67860SUPPL2021-06-22
62952SUPPL2020-05-13
62950SUPPL2020-05-13
59864SUPPL2019-08-28
59858ORIG2019-08-28
57928SUPPL2019-03-07
57860SUPPL2019-03-01
57575SUPPL2019-02-13
57345SUPPL2019-01-25
51010SUPPL2018-01-10
51003SUPPL2018-01-09
48140SUPPL2017-04-27
48101SUPPL2017-04-25
38934SUPPL2013-03-01
7734SUPPL2013-03-01
30015SUPPL2010-11-22
17821SUPPL2010-11-12
38933SUPPL2004-08-25
30014SUPPL2004-08-25