Treats negative nitrogen balance. ANDA 20512, held by Baxter Hlthcare. Amino Acids.
As of Nov 15, 2026, ANDA 20512 (Clinisol 15% Sulfite Free In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Aug 30, 1996, with 6 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: the alimentary tract cannot or should not be used, gastrointestinal absorption of protein is impaired, or metabolic requirements for protein are substantially increased, as with extensive burns.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 1996 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clinisol 15% Sulfite Free In Plastic Container15% (15GM/100ML) · injectable;injection | Amino Acids | Rx |
| Dec 4, 2003 | Supplement 7Labeling | Approved | None posted |
| Feb 28, 2001 | Supplement 5Labeling | Approved | None posted |
| Jan 28, 2000 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1999 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 1, 1999 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1999 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1996 | 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
