Documents
Application Sponsors
| NDA 020955 | SANOFI AVENTIS US | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 62.5MG/5ML | 1 | FERRLECIT | SODIUM FERRIC GLUCONATE COMPLEX |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1999-02-18 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2001-02-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-04-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 5 | AP | 2002-06-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2004-08-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 10 | AP | 2006-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2011-08-25 | UNKNOWN |
| LABELING; Labeling | SUPPL | 15 | AP | 2011-08-25 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2013-02-01 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 2020-03-31 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2020-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2022-03-16 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 8 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 15 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 6 |
TE Codes
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 20955
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"FERRLECIT","activeIngredients":"SODIUM FERRIC GLUCONATE COMPLEX","strength":"62.5MG\/5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
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[originalApprovals] => [{"actionDate":"FERRLECIT","submission":"SODIUM FERRIC GLUCONATE COMPLEX","actionType":"62.5MG\/5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-12-02
)
)