Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206604
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FERUMOXYTOL | FERUMOXYTOL | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION;INTRAVENOUS | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/15/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206604Orig1s000ltr.pdf |
FERUMOXYTOL
SOLUTION;INTRAVENOUS; EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FERAHEME | FERUMOXYTOL | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AB | 022180 | COVIS |
| FERUMOXYTOL | FERUMOXYTOL | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AB | 206604 | SANDOZ |