ANDA 91112, held by B Braun. Amino Acids.
As of Nov 15, 2026, ANDA 91112 (Amino Acids), held by B Braun, was first approved by FDA on Apr 13, 2012, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Plenamine 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when: — Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy; — Bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks; — Tube feeding methods alone cannot provide adequate nutrition.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 13, 2012 | Original application | Approved | None posted |
| Amino Acids15%(150GM/1000ML) · injectable;injection | Amino Acids | Rx |
| Amino Acids15%(300GM/2000ML) · injectable;injection | Amino Acids | Rx |
| Jan 25, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 13, 2012 | 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
