NDA 204078, held by Exela Pharma. Neostigmine Methylsulfate.
As of Nov 13, 2026, NDA 204078 (Bloxiverz), held by Exela Pharma, was first approved by FDA on May 31, 2013, with 8 approved supplements and 0 published complete response letters.
BLOXIVERZ, is a cholinesterase inhibitor, indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 31, 2013 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Bloxiverz5MG/10ML (0.5MG/ML) · solution;intravenous | Neostigmine Methylsulfate | DiscontinuedReference drug |
| Bloxiverz10MG/10ML (1MG/ML) · solution;intravenous | Neostigmine Methylsulfate | DiscontinuedReference drug |
| Bloxiverz5MG/5ML (1MG/ML) · solution;intravenous | Neostigmine Methylsulfate | DiscontinuedReference drug |
| Oct 27, 2023 | Supplement 14Manufacturing | Approved | |
| Jan 19, 2021 | Supplement 10Labeling · Standard review | Approved | |
| Oct 20, 2015 | Supplement 7Labeling · Standard review | Approved | |
| Dec 11, 2014 | Supplement 4Labeling · Standard review | Approved | |
| Dec 2, 2014 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 30, 2014 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 22, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jun 18, 2014 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| May 31, 2013 | Original applicationNew formulation or manufacturer · Standard 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
