Documents
Application Sponsors
| NDA 050420 | SANOFI AVENTIS US | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 300MG | 1 | RIFADIN | RIFAMPIN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 1971-05-21 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1982-10-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1982-11-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1982-11-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1982-11-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1977-05-25 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1990-02-12 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1983-09-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1990-02-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1984-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1986-02-18 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1984-09-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1989-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1987-11-16 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1971-08-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1971-12-06 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1972-01-26 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1982-03-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1972-06-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1972-08-31 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1972-09-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1972-10-05 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1973-01-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1973-05-09 | |
| LABELING; Labeling | SUPPL | 25 | AP | 1973-11-20 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1973-10-11 | |
| LABELING; Labeling | SUPPL | 27 | AP | 1974-01-24 | |
| LABELING; Labeling | SUPPL | 28 | AP | 1974-03-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1974-03-28 | |
| LABELING; Labeling | SUPPL | 30 | AP | 1974-05-29 | |
| LABELING; Labeling | SUPPL | 31 | AP | 1974-05-21 | |
| LABELING; Labeling | SUPPL | 32 | AP | 1974-11-26 | |
| LABELING; Labeling | SUPPL | 33 | AP | 1975-01-30 | |
| LABELING; Labeling | SUPPL | 34 | AP | 1975-09-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1975-10-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1975-08-28 | |
| LABELING; Labeling | SUPPL | 37 | AP | 1976-03-29 | |
| LABELING; Labeling | SUPPL | 38 | AP | 1976-01-19 | |
| LABELING; Labeling | SUPPL | 39 | AP | 1976-01-28 | |
| LABELING; Labeling | SUPPL | 40 | AP | 1976-02-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1976-03-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1976-08-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1976-08-09 | |
| LABELING; Labeling | SUPPL | 44 | AP | 1976-12-21 | |
| LABELING; Labeling | SUPPL | 45 | AP | 1977-06-29 | |
| LABELING; Labeling | SUPPL | 46 | AP | 1978-02-10 | |
| LABELING; Labeling | SUPPL | 47 | AP | 1978-05-30 | |
| LABELING; Labeling | SUPPL | 48 | AP | 1978-06-29 | |
| LABELING; Labeling | SUPPL | 49 | AP | 1979-06-26 | |
| LABELING; Labeling | SUPPL | 50 | AP | 1979-03-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1979-04-16 | |
| LABELING; Labeling | SUPPL | 52 | AP | 1979-04-16 | |
| LABELING; Labeling | SUPPL | 53 | AP | 1979-05-01 | |
| LABELING; Labeling | SUPPL | 54 | AP | 1979-07-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 1979-10-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 1979-10-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 1980-07-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 1980-12-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 1982-09-11 | |
| LABELING; Labeling | SUPPL | 60 | AP | 1981-10-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 1981-10-20 | |
| LABELING; Labeling | SUPPL | 63 | AP | 1993-06-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 1996-01-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 1994-07-12 | |
| LABELING; Labeling | SUPPL | 67 | AP | 1996-09-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 1995-09-05 | |
| LABELING; Labeling | SUPPL | 70 | AP | 2000-04-12 | STANDARD |
| LABELING; Labeling | SUPPL | 71 | AP | 2000-04-12 | STANDARD |
| LABELING; Labeling | SUPPL | 72 | AP | 2004-08-20 | STANDARD |
| LABELING; Labeling | SUPPL | 73 | AP | 2010-11-10 | STANDARD |
| LABELING; Labeling | SUPPL | 75 | AP | 2013-02-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 76 | AP | 2017-04-24 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 77 | AP | 2018-01-08 | STANDARD |
| LABELING; Labeling | SUPPL | 78 | AP | 2019-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 80 | AP | 2019-02-28 | STANDARD |
| LABELING; Labeling | SUPPL | 83 | AP | 2019-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 84 | AP | 2020-05-12 | STANDARD |
| LABELING; Labeling | SUPPL | 85 | AP | 2021-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 86 | AP | 2021-10-21 | STANDARD |
| LABELING; Labeling | SUPPL | 87 | AP | 2022-01-29 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 66 | Null | 0 |
| SUPPL | 68 | Null | 0 |
| SUPPL | 73 | Null | 6 |
| SUPPL | 75 | Null | 15 |
| SUPPL | 76 | Null | 15 |
| SUPPL | 77 | Null | 6 |
| SUPPL | 78 | Null | 6 |
| SUPPL | 80 | Null | 7 |
| SUPPL | 83 | Null | 15 |
| SUPPL | 84 | Null | 6 |
| SUPPL | 85 | Null | 6 |
| SUPPL | 86 | Null | 7 |
| SUPPL | 87 | Null | 7 |
TE Codes
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 50420
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"RIFADIN","activeIngredients":"RIFAMPIN","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"05\/12\/2020","submission":"SUPPL-84","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050420s084,050627s027lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2019","submission":"SUPPL-83","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050420s083,050627s025lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2019","submission":"SUPPL-80","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050420s080,050627s023lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2019","submission":"SUPPL-78","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050420s078,050627s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/08\/2018","submission":"SUPPL-77","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050420s077,050627s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2017","submission":"SUPPL-76","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050420s076,050627s017lbl.pdf\"}]","notes":"Please see"},{"actionDate":"02\/27\/2013","submission":"SUPPL-75","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050420s075,050627s014lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2010","submission":"SUPPL-73","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050420s073,050627s012lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2004","submission":"SUPPL-72","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50420s072,50627s008lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"RIFADIN","submission":"RIFAMPIN","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-05-12
)
)