NDA 20645, held by Bausch. Sodium Benzoate; Sodium Phenylacetate.
As of Nov 13, 2026, NDA 20645 (Ammonul), held by Bausch, was first approved by FDA on Feb 17, 2005, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 17, 2005 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ammonul10%;10% (5GM/50ML;5GM/50ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous | Sodium Benzoate; Sodium Phenylacetate | DiscontinuedReference drug |
| Dec 22, 2020 | Supplement 12Labeling · Standard review | Approved | |
| Jan 10, 2017 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Aug 7, 2013 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Jun 30, 2011 | Supplement 8Labeling | Approved | |
| Feb 17, 2005 | Original applicationNew dosage form · Priority review | Approved |
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
