Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020091
Company: ALLIANCE PHARM
Company: ALLIANCE PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMAGENT | PERFLUBRON | 100% | LIQUID;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 |
|---|---|---|---|---|---|---|---|
| 08/13/1993 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/27/1996 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/30/1994 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/22/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |