Details for New Drug Application (NDA): 204770
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NDA 204770 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 204770
| Tradename: | METAXALONE |
| Applicant: | Lannett Co Inc |
| Ingredient: | metaxalone |
| Patents: | 0 |
Pharmacology for NDA: 204770
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 204770
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METAXALONE | metaxalone | TABLET;ORAL | 204770 | ANDA | Lannett Company, Inc. | 0527-1435 | 0527-1435-01 | 100 TABLET in 1 BOTTLE (0527-1435-01) |
| METAXALONE | metaxalone | TABLET;ORAL | 204770 | ANDA | Lannett Company, Inc. | 0527-1435 | 0527-1435-05 | 500 TABLET in 1 BOTTLE (0527-1435-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Nov 22, 2016 | TE: | AB | RLD: | No | ||||
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