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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Federal Trade Commission

Generated: August 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074278

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NDA 074278 describes LEVORPHANOL TARTRATE, which is a drug marketed by Sentynl Theraps Inc and is included in one NDA. It is available from one supplier. Additional details are available on the LEVORPHANOL TARTRATE profile page.

The generic ingredient in LEVORPHANOL TARTRATE is levorphanol tartrate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the levorphanol tartrate profile page.
Summary for 074278
Applicant:Sentynl Theraps Inc
Ingredient:levorphanol tartrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 074278
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 074278
Suppliers and Packaging for NDA: 074278
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVORPHANOL TARTRATE levorphanol tartrate TABLET;ORAL 074278 ANDA Sentynl Therapeutics, Inc. 42358-102 N 42358-102-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Mar 31, 2000TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jun 18, 2018TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Jun 18, 2018TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts

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