Drugs@FDA: FDA-Approved Drugs
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOSYN 3.5% | AMINO ACIDS | 3.5% (3.5GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| AMINOSYN 3.5% M | AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE | 3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| AMINOSYN 3.5% M | AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE | 3.5%;21MG/100ML;128MG/100ML;234MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| AMINOSYN 7% W/ ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 7%;102MG/100ML;522MG/100ML;410MG/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 |
|---|---|---|---|---|---|---|---|
| 05/14/1976 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 10/25/2002 | SUPPL-52 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm052,etc,ltr.pdf |
| 06/12/2003 | SUPPL-51 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17673slr065,17789slr051ltr.pdf |
| 01/22/1999 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1997 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1994 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1993 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/18/1992 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1992 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/1987 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1985 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/04/1984 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 07/05/1983 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1983 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/13/1983 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 10/13/1983 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1982 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1984 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 12/07/1981 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 09/15/1981 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 09/15/1981 | SUPPL-29 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/04/1981 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1981 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1981 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 05/29/1981 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/27/1980 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1980 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 11/26/1979 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1979 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1980 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1980 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/27/1978 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/12/1979 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/13/1979 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/02/1979 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/09/1979 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/09/1979 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/04/1979 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/19/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1978 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1977 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1977 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/11/1977 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1978 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/23/1976 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |