U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019437
Company: ICU MEDICAL INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOSYN II 10% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 3.5% M AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 7% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 8.5% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML INJECTABLE;INJECTION Discontinued None No No
AMINOSYN II 8.5% W/ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC 8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/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
04/03/1986 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
06/06/2016 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.
07/31/2013 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
10/25/2002 SUPPL-15 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
06/23/2003 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19437slr014ltr.pdf
01/22/1999 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
05/05/1997 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
08/27/1996 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
07/11/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
12/30/1993 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
09/28/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
08/18/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
02/10/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
06/17/1988 SUPPL-5 Labeling

Label is not available on this site.
12/01/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
12/04/1986 SUPPL-2 Labeling

Label is not available on this site.
12/04/1986 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.
Back to Top