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Last Updated: June 27, 2022

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. 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. Forty-two 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:0
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)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Mar 3, 1995TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 3, 1995TE:ABRLD:Yes

Expired US Patents for NDA 020281

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ULTRAM tramadol hydrochloride TABLET;ORAL 020281-001 Mar 3, 1995 See Plans and Pricing See Plans and Pricing
Janssen Pharms ULTRAM tramadol hydrochloride TABLET;ORAL 020281-002 Mar 3, 1995 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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