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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 212024


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NDA 212024 describes LEVORPHANOL TARTRATE, which is a drug marketed by Hikma, Novitium Pharma, Specgx Llc, Sun Pharm Inds Inc, and Virtus, and is included in five NDAs. It is available from six 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. Six suppliers are listed for this compound. Additional details are available on the levorphanol tartrate profile page.
Summary for 212024
Tradename:LEVORPHANOL TARTRATE
Applicant:Specgx Llc
Ingredient:levorphanol tartrate
Patents:0
Pharmacology for NDA: 212024
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 212024
Suppliers and Packaging for NDA: 212024
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVORPHANOL TARTRATE levorphanol tartrate TABLET;ORAL 212024 ANDA SpecGx LLC 0406-2224 0406-2224-01 100 TABLET in 1 BOTTLE, PLASTIC (0406-2224-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Dec 13, 2019TE:ABRLD:No

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