Details for New Drug Application (NDA): 021123

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NDA 021123 describes ULTRACET, which is a drug marketed by Janssen Pharms and is included in one NDA. Additional details are available on the ULTRACET profile page.

The generic ingredient in ULTRACET is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Summary for 021123

Tradename:	ULTRACET
Applicant:	Janssen Pharms
Ingredient:	acetaminophen; tramadol hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	325MG;37.5MG
Approval Date:	Aug 15, 2001	TE:		RLD:	Yes

Expired US Patents for NDA 021123

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ULTRACET	acetaminophen; tramadol hydrochloride	TABLET;ORAL	021123-001	Aug 15, 2001	5,336,691	⤷ Get Started Free
Janssen Pharms	ULTRACET	acetaminophen; tramadol hydrochloride	TABLET;ORAL	021123-001	Aug 15, 2001	RE39221	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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