FdaApplication
NDA 203565
Identifiers
- fda_app_no: NDA203565
Properties
| Property | Value |
|---|---|
| applicant_name | AMERICAN REGENT INC |
| application_type | NDA |
| approval_date | 2013-07-25 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| INJECTAFER | FERRIC CARBOXYMALTOSE | 100MG IRON/2ML (50MG IRON/ML) | SOLUTION;INTRAVENOUS |
| INJECTAFER | FERRIC CARBOXYMALTOSE | 500MG IRON/10ML (50MG IRON/ML) | SOLUTION;INTRAVENOUS |
| INJECTAFER | FERRIC CARBOXYMALTOSE | 750MG IRON/15ML (50MG IRON/ML) | SOLUTION;INTRAVENOUS |
| INJECTAFER | FERRIC CARBOXYMALTOSE | 1GM IRON/20ML (50MG IRON/ML) | SOLUTION;INTRAVENOUS |
4 products