Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078215
Company: WEST-WARD PHARMS INT
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE | FERRIC OXYHYDROXIDE | EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/31/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078215s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/28/2012 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2012 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
INJECTABLE;INJECTION; EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FERRLECIT | FERRIC OXYHYDROXIDE | EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) | INJECTABLE;INJECTION | Prescription | Yes | AB | 020955 | SANOFI AVENTIS US |
| SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE | FERRIC OXYHYDROXIDE | EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) | INJECTABLE;INJECTION | Prescription | No | AB | 078215 | WEST-WARD PHARMS INT |