For extensive burns. ANDA 75880, held by Baxter Hlthcare. Amino Acids.
As of Nov 15, 2026, ANDA 75880 (Premasol 6% In Plastic Container, Premasol 10% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Jun 19, 2003, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE PREMASOL 10% injection is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with PREMASOL 10% injection is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; gastrointestinal absorption of protein is impaired; or protein requirements are substantially increased as with extensive burns.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 19, 2003 | Original application | Approved | None posted |
| Premasol 6% In Plastic Container6% (6GM/100ML) · injectable;injection | Amino Acids | Rx |
| Premasol 10% In Plastic Container10% (10GM/100ML) · injectable;injection | Amino Acids | Rx |
| Feb 6, 2006 | Supplement 6Labeling | Approved | None posted |
| Aug 23, 2004 | Supplement 1Labeling | Approved | None posted |
| Jun 19, 2003 | Original application | 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
