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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

Sentynl Theraps Inc
levorphanol tartrate
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:Yes

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.