Details for New Drug Application (NDA): 219843
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NDA 219843 describes ATMEKSI, which is a drug marketed by Rosemont Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ATMEKSI profile page.
The generic ingredient in ATMEKSI is methocarbamol. There are twenty-seven drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the methocarbamol profile page.
The generic ingredient in ATMEKSI is methocarbamol. There are twenty-seven drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the methocarbamol profile page.
Summary for 219843
| Tradename: | ATMEKSI |
| Applicant: | Rosemont Pharms |
| Ingredient: | methocarbamol |
| Patents: | 1 |
Pharmacology for NDA: 219843
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 219843
Suppliers and Packaging for NDA: 219843
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATMEKSI | methocarbamol | SUSPENSION;ORAL | 219843 | NDA | Rosemont Pharmaceuticals LLC | 69528-701 | 69528-701-05 | 150 mL in 1 BOTTLE (69528-701-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 750MG/5ML | ||||
| Approval Date: | Jul 30, 2025 | TE: | RLD: | Yes | |||||
| Patent: | 12,390,439 | Patent Expiration: | Oct 9, 2044 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ATMEKSI IS INDICATED AS AN ADJUNCT TO REST, PHYSICAL THERAPY, AND OTHER MEASURES FOR THE RELIEF AND DISCOMFORT ASSOCIATED WITH ACUTE, PAINFUL MUSCULOSKELETAL CONDITIONS | ||||||||
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