FDA approved the original new drug application for ATMEKSI on July 30, 2025, sponsored by ROSEMONT PHARMS. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA219843
- Sponsor
- ROSEMONT PHARMS
- Original approval
- Review
- standard review
- Active ingredient
- methocarbamol
Browse every approval whose brand starts with A, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| methocarbamol 750MG/5ML | SUSPENSION | ORAL | Prescription |
| methocarbamol 750MG(5ML) | SUSPENSION | ORAL | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to ROSEMONT PHARMS
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