Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017789
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 Prescription 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 Prescription 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 Prescription 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.

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