Details for New Drug Application (NDA): 022503
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The generic ingredient in METAXALONE is metaxalone. There are twenty drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the metaxalone profile page.
Summary for 022503
Tradename: | METAXALONE |
Applicant: | Primus Pharms |
Ingredient: | metaxalone |
Patents: | 1 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022503
Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 022503
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METAXALONE | metaxalone | TABLET;ORAL | 022503 | NDA | Primus Pharmaceuticals | 68040-712 | 68040-712-38 | 100 TABLET in 1 BOTTLE (68040-712-38) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jun 1, 2015 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 29, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? |
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