Drugs@FDA: FDA-Approved Drugs
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SORBITOL-MANNITOL IN PLASTIC CONTAINER | MANNITOL; SORBITOL | 540MG/100ML;2.7GM/100ML | SOLUTION;IRRIGATION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/22/1980 | 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 |
|---|---|---|---|---|---|
| 08/21/1997 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1997 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/05/1999 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 03/28/1997 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/27/1996 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1995 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1991 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/28/1992 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/10/1991 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/11/1990 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1987 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1986 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1986 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1986 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1985 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1986 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 02/22/1986 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1985 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/1984 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1989 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1984 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1984 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/22/1984 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1981 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1982 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/15/1980 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1980 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1980 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/1980 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |