Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020410
Company: AMAG PHARMS INC
Company: AMAG PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GASTROMARK | FERUMOXSIL | EQ 0.175MG IRON/ML | SUSPENSION;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 12/06/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/05/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |