Details for New Drug Application (NDA): 208774
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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 208774
Tradename: | METAXALONE |
Applicant: | Appco |
Ingredient: | metaxalone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208774
Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 208774
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METAXALONE | metaxalone | TABLET;ORAL | 208774 | ANDA | Medsource Pharmaceuticals | 45865-161 | 45865-161-30 | 30 TABLET in 1 BOTTLE (45865-161-30) |
METAXALONE | metaxalone | TABLET;ORAL | 208774 | ANDA | Medsource Pharmaceuticals | 45865-161 | 45865-161-60 | 60 TABLET in 1 BOTTLE (45865-161-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Sep 24, 2018 | TE: | BX | RLD: | No |
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