Documents
Application Sponsors
| NDA 020625 | SANOFI AVENTIS US | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | ALLEGRA | FEXOFENADINE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1996-07-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-01-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1998-01-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-07-06 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1998-12-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-01-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-01-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2003-05-12 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2001-07-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2003-05-12 | PRIORITY |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 8 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 8 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 20625
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"ALLEGRA","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"05\/12\/2003","submission":"SUPPL-12","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2003","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20872se8-003,20625se8-010_allegra_lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/1996","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20625lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ALLEGRA","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2003-05-12
)
)