Details for New Drug Application (NDA): 204770
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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 204770
Tradename: | METAXALONE |
Applicant: | Lannett Co Inc |
Ingredient: | metaxalone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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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