Details for New Drug Application (NDA): 203695
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NDA 203695 describes METAXALONE, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Ingenus Pharms Llc, Lannett Co Inc, Mountain, Primus Pharms, Rising, Sandoz, and Sciegen Pharms Inc, and is included in nine NDAs. It is available from thirty-four suppliers. There is one patent protecting this drug. Additional details are available on the METAXALONE profile page.
The generic ingredient in METAXALONE is metaxalone. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the metaxalone profile page.
The generic ingredient in METAXALONE is metaxalone. There are twenty drug master file entries for this compound. Thirty-four 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 |
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 | ||||
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