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Last Updated: October 20, 2020

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Details for New Drug Application (NDA): 213479

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NDA 213479 describes LEVORPHANOL TARTRATE, which is a drug marketed by Novitium Pharma, Sentynl Theraps Inc, Specgx Llc, and Virtus Pharms, and is included in four NDAs. It is available from four suppliers. Additional details are available on the LEVORPHANOL TARTRATE profile page.

The generic ingredient in LEVORPHANOL TARTRATE is levorphanol tartrate. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the levorphanol tartrate profile page.
Summary for 213479
Tradename:LEVORPHANOL TARTRATE
Applicant:Novitium Pharma
Ingredient:levorphanol tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 213479
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 213479
Suppliers and Packaging for NDA: 213479
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVORPHANOL TARTRATE levorphanol tartrate TABLET;ORAL 213479 ANDA Lannett Company, Inc. 0527-3236 0527-3236-37 100 TABLET in 1 BOTTLE (0527-3236-37)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jul 1, 2020TE:ABRLD:No

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