Details for New Drug Application (NDA): 203695
✉ Email this page to a colleague
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 203695
Tradename: | METAXALONE |
Applicant: | Actavis Labs Fl Inc |
Ingredient: | metaxalone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203695
Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 203695
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METAXALONE | metaxalone | TABLET;ORAL | 203695 | ANDA | Actavis Pharma, Inc. | 0591-2341 | 0591-2341-01 | 100 TABLET in 1 BOTTLE (0591-2341-01) |
METAXALONE | metaxalone | TABLET;ORAL | 203695 | ANDA | medsource pharmaceuticals | 45865-985 | 45865-985-30 | 30 TABLET in 1 BOTTLE (45865-985-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Jun 15, 2017 | TE: | AB | RLD: | No |
Complete Access Available with Subscription