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Generated: April 25, 2017

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Details for New Drug Application (NDA): 040486

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NDA 040486 describes METAXALONE, which is a drug marketed by Corepharma, Sandoz, Lannett Holdings Inc, Impax Labs Inc, and Amneal Pharms, and is included in five NDAs. It is available from twenty-four suppliers. Additional details are available on the METAXALONE profile page.

The generic ingredient in METAXALONE is metaxalone. There are nineteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

Summary for NDA: 040486

Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details

Pharmacology for NDA: 040486

Suppliers and Packaging for NDA: 040486

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 040486 ANDA CorePharma, LLC 64720-126 64720-126-10 100 TABLET in 1 BOTTLE (64720-126-10)
TABLET;ORAL 040486 ANDA Keltman Pharmaceuticals Inc. 68387-108 68387-108-30 30 TABLET in 1 BOTTLE, PLASTIC (68387-108-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Feb 27, 2015TE:RLD:No

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