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 Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 020281

Analgesics, Opioid
Narcotics

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:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 3, 1995	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Mar 3, 1995	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020281

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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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