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Details for New Drug Application (NDA): 203399

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NDA 203399 describes METAXALONE, which is a drug marketed by Corepharma, Sandoz, and Amneal Pharms, and is included in four NDAs. It is available from twenty-two 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-five suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

Summary for NDA: 203399

Amneal Pharms
Therapeutic Class:Skeletal Muscle Relaxants

Pharmacology for NDA: 203399

Suppliers and Packaging for NDA: 203399

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 203399 ANDA Blenheim Pharmacal, Inc. 10544-144 10544-144-09 9 TABLET in 1 BOTTLE (10544-144-09)
TABLET;ORAL 203399 ANDA Blenheim Pharmacal, Inc. 10544-144 10544-144-12 12 TABLET in 1 BOTTLE (10544-144-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Jun 21, 2013TE:ABRLD:No

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