FDA.reportPublic FDA data

Application 050705

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIFATERISONIAZID; PYRAZINAMIDE; RIFAMPINTABLET;ORAL50MG;300MG;120MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0088-0576Rifaterrifampin, isoniazid and pyrazinamidesanofi-aventis U.S. LLCNDACurrent
0088-0576Rifaterrifampin, isoniazid and pyrazinamidesanofi-aventis U.S. LLCNDACurrent
0088-0576Rifaterrifampin, isoniazid and pyrazinamidesanofi-aventis U.S. LLCNDACurrent
0088-0576Rifaterrifampin, isoniazid and pyrazinamidesanofi-aventis U.S. LLCNDACurrent
0088-0576Rifaterrifampin, isoniazid and pyrazinamidesanofi-aventis U.S. LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84406SUPPL 2025-12-15
84369SUPPL 2025-12-09
83705SUPPL 2025-10-09
83698SUPPL 2025-10-09
81122SUPPL 2025-02-07
81076SUPPL 2025-02-06
79871SUPPL 2024-10-11
79866SUPPL 2024-10-11
76768SUPPL 2023-12-12
76756SUPPL 2023-12-11
75125SUPPL 2023-08-18
75100SUPPL 2023-08-17
73498SUPPL 2023-02-14
73460SUPPL 2023-02-13
70048SUPPL2022-02-02
69997SUPPL2022-01-31
69086SUPPL2021-10-25
69083SUPPL2021-10-25
67874SUPPL2021-06-23
67865SUPPL2021-06-22
62959SUPPL2020-05-13
62948SUPPL2020-05-13
59862SUPPL2019-08-28
59860SUPPL2019-08-28
57930SUPPL2019-03-07
57862SUPPL2019-03-01
57529SUPPL2019-02-13
57344SUPPL2019-01-25
51012SUPPL2018-01-10
51002SUPPL2018-01-09
48139SUPPL2017-04-27
48098SUPPL2017-04-25
39137SUPPL2013-03-01
8038SUPPL2013-03-01
8037SUPPL2010-11-22
39136SUPPL2010-11-17
18044SUPPL2009-01-02
30303SUPPL2008-12-29
18043SUPPL2005-05-02
8036SUPPL2005-05-02