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Details for New Drug Application (NDA): 016862

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NDA 016862 describes DARVON-N, which is a drug marketed by Aaipharma Llc and Xanodyne Pharm and is included in four NDAs. It is available from one supplier. Additional details are available on the DARVON-N profile page.

The generic ingredient in DARVON-N is aspirin; propoxyphene napsylate. There are twenty-one drug master file entries for this compound. Additional details are available on the aspirin; propoxyphene napsylate profile page.

Summary for NDA: 016862

Tradename:
DARVON-N
Applicant:
Xanodyne Pharm
Ingredient:
propoxyphene napsylate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 016862

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 016862

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DARVON-N
propoxyphene napsylate
TABLET;ORAL 016862 NDA Stat Rx USA 16590-874 16590-874-30 30 TABLET, FILM COATED in 1 BOTTLE (16590-874-30)
DARVON-N
propoxyphene napsylate
TABLET;ORAL 016862 NDA Stat Rx USA 16590-874 16590-874-60 60 TABLET, FILM COATED in 1 BOTTLE (16590-874-60)

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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