Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017673
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOSYN 10% AMINO ACIDS 10% (10GM/100ML) INJECTABLE;INJECTION Prescription None No No
AMINOSYN 10% (PH6) AMINO ACIDS 10% (10GM/100ML) INJECTABLE;INJECTION Prescription None No No
AMINOSYN 5% AMINO ACIDS 5% (5GM/100ML) INJECTABLE;INJECTION Prescription None No No
AMINOSYN 7% AMINO ACIDS 7% (7GM/100ML) INJECTABLE;INJECTION Prescription None No No
AMINOSYN 7% (PH6) AMINO ACIDS 7% (7GM/100ML) INJECTABLE;INJECTION Prescription None No No
AMINOSYN 8.5% AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE;INJECTION Prescription None No No
AMINOSYN 8.5% (PH6) AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE;INJECTION Prescription None No No
AMINOSYN 8.5% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 8.5%;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
12/03/1975 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
07/28/2016 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

01/15/2016 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

07/31/2013 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

03/09/2004 SUPPL-69 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17673scp069ltr.pdf
03/28/2003 SUPPL-67 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17673scs067ltr.pdf
10/25/2002 SUPPL-66 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-65 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17673slr065,17789slr051ltr.pdf
05/05/1997 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1996 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1996 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

07/11/1994 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

12/30/1993 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1992 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

02/10/1992 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

07/13/1987 SUPPL-57 Labeling

Label is not available on this site.

07/13/1987 SUPPL-56 Labeling

Label is not available on this site.

01/31/1986 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1985 SUPPL-52 Labeling

Label is not available on this site.

10/26/1985 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/1985 SUPPL-50 Labeling

Label is not available on this site.

03/11/1985 SUPPL-49 Labeling

Label is not available on this site.

03/11/1985 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/1984 SUPPL-47 Labeling

Label is not available on this site.

10/13/1983 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1983 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1983 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1983 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1983 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1982 SUPPL-41 Labeling

Label is not available on this site.

06/29/1982 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

03/12/1982 SUPPL-39 Labeling

Label is not available on this site.

01/20/1982 SUPPL-38 Labeling

Label is not available on this site.

04/10/1985 SUPPL-37 Labeling

Label is not available on this site.

05/16/1981 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/02/1981 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1980 SUPPL-34 Labeling

Label is not available on this site.

05/29/1981 SUPPL-33 Labeling

Label is not available on this site.

05/29/1981 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1980 SUPPL-31 Labeling

Label is not available on this site.

11/26/1979 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1979 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1979 SUPPL-28 Labeling

Label is not available on this site.

09/04/1979 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1979 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1979 SUPPL-25 Labeling

Label is not available on this site.

05/16/1979 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1980 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/1978 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1979 SUPPL-21 Labeling

Label is not available on this site.

03/22/1978 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/17/1978 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1979 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/1977 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1977 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/13/1977 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1977 SUPPL-12 Labeling

Label is not available on this site.

12/08/1977 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/26/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1976 SUPPL-9 Labeling

Label is not available on this site.

09/09/1976 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1978 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1978 SUPPL-6 Labeling

Label is not available on this site.

08/27/1976 SUPPL-5 Efficacy

Label is not available on this site.

08/27/1976 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1976 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1978 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1978 SUPPL-1 Labeling

Label is not available on this site.

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