NDA 20107, held by Baxter Hlthcare. Amino Acids.
As of Nov 13, 2026, NDA 20107 (Novamine 15% Sulfite Free In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Feb 5, 1993, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 5, 1993 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Novamine 15% Sulfite Free In Plastic Container15% (15GM/100ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Amino Acids | Discontinued |
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
