Details for New Drug Application (NDA): 203399
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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 203399
Tradename: | METAXALONE |
Applicant: | Amneal Pharms |
Ingredient: | metaxalone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203399
Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 203399
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METAXALONE | metaxalone | TABLET;ORAL | 203399 | ANDA | AvPAK | 50268-530 | 50268-530-15 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-530-15) / 1 TABLET in 1 BLISTER PACK (50268-530-11) |
METAXALONE | metaxalone | TABLET;ORAL | 203399 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-553 | 53746-553-01 | 100 TABLET in 1 BOTTLE (53746-553-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Jun 21, 2013 | TE: | AB | RLD: | No |
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