Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018316
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.

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.

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.

01/28/1992 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

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.

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