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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 two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the levorphanol tartrate profile page.

Summary for NDA: 074278

Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 074278

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 074278

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
levorphanol tartrate
TABLET;ORAL 074278 ANDA Roxane Laboratories, Inc 0054-0438 0054-0438-25 100 TABLET in 1 BOTTLE, PLASTIC (0054-0438-25)
levorphanol tartrate
TABLET;ORAL 074278 ANDA Sentynl Therapeutics, Inc. 42358-102 42358-102-10 100 TABLET in 1 BOTTLE, PLASTIC (42358-102-10)

Summary for product number 001

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

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