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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020281

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NDA 020281 describes ULTRAM, which is a drug marketed by Janssen Pharms and Valeant Pharms and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the ULTRAM profile page.

The generic ingredient in ULTRAM is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.
Summary for 020281
Tradename:ULTRAM
Applicant:Janssen Pharms
Ingredient:tramadol hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 020281
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 020281
Suppliers and Packaging for NDA: 020281
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULTRAM tramadol hydrochloride TABLET;ORAL 020281 NDA Janssen Pharmaceuticals, Inc. 50458-659 50458-659-60 100 TABLET, COATED in 1 BOTTLE (50458-659-60)
Paragraph IV (Patent) Challenges for 020281
Tradename Dosage Ingredient NDA Submissiondate
ULTRAM TABLET;ORAL tramadol hydrochloride 020281

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Mar 3, 1995TE:RLD:No
Patent:  Start TrialPatent Expiration:Apr 12, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 3, 1995TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Apr 12, 2020Product Flag?Substance Flag?Delist Request?Y

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