Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 020345
Company: ICU MEDICAL INC
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOSYN-HF 8% | AMINO ACIDS | 8% (8GM/100ML) | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 04/04/1996 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 09/15/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/29/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |