NDA 19682, held by Hospira Inc. Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate, Amino Acids; Dextrose; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride.
As of Nov 13, 2026, NDA 19682 (Aminosyn Ii 3.5% M In Dextrose 5% In Plastic Container, Aminosyn Ii 4.25% M In Dextrose 10% In Plastic Container, Aminosyn Ii 4.25% W/ Elect And Adjusted Phosphate In Dextrose 10% In Plastic Container), held by Hospira Inc, was first approved by FDA on Nov 1, 1988, with 19 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 1, 1988 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aminosyn Ii 3.5% M In Dextrose 5% In Plastic Container3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML · injectable;injection | Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate | Discontinued |
| Aminosyn Ii 4.25% M In Dextrose 10% In Plastic Container4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML · injectable;injection | Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate | Discontinued |
| Aminosyn Ii 4.25% W/ Elect And Adjusted Phosphate In Dextrose 10% In Plastic Container4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML · injectable;injection | Amino Acids; Dextrose; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 2003 | Supplement 20Manufacturing · Standard review | Approved | |
| Nov 8, 2002 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Aug 21, 2002 | Supplement 15Labeling · Standard review | Approved | |
| Aug 21, 2002 | Supplement 18Labeling · Standard review | Approved | |
| Dec 29, 1998 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1998 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| May 5, 1997 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1997 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1994 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1993 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1992 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1992 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Nov 1, 1988 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
