FDA.reportPublic FDA data

Application 050627

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIFADINRIFAMPININJECTABLE;INJECTION600MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0597Rifadin IVrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0599Rifadin IV NOVAPLUSrifampinSanofi-Aventis U.S. LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84408SUPPL 2025-12-15
84372SUPPL 2025-12-09
83707SUPPL 2025-10-09
83700SUPPL 2025-10-09
79873SUPPL 2024-10-11
79864SUPPL 2024-10-11
76767SUPPL 2023-12-12
76759SUPPL 2023-12-11
75122SUPPL 2023-08-18
75105SUPPL 2023-08-17
73582SUPPL 2023-02-21
73573SUPPL 2023-02-21
73496SUPPL 2023-02-14
73459SUPPL 2023-02-13
70050SUPPL2022-02-02
70001SUPPL2022-01-31
69078SUPPL2021-10-22
69067SUPPL2021-10-22
67873SUPPL2021-06-23
67861SUPPL2021-06-22
62953SUPPL2020-05-13
62951SUPPL2020-05-13
59863SUPPL2019-08-28
59859ORIG2019-08-28
57929SUPPL2019-03-07
57861SUPPL2019-03-01
57576SUPPL2019-02-13
57346SUPPL2019-01-25
51011SUPPL2018-01-10
51004SUPPL2018-01-09
48141SUPPL2017-04-27
48100SUPPL2017-04-25
30188SUPPL2013-03-01
17948SUPPL2013-03-01
7900SUPPL2010-11-22
39051SUPPL2010-11-12
39050SUPPL2004-08-25
7899SUPPL2004-08-25