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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
US Army
Colorcon
Moodys
Cantor Fitzgerald
Argus Health
Covington
Deloitte
Cipla

Generated: May 24, 2018

DrugPatentWatch Database Preview

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. It is available from four suppliers. 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. Thirty-six 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021123
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 021123
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123 NDA Rebel Distributors Corp 21695-143 E 21695-143-72
ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123 NDA Janssen Pharmaceuticals, Inc. 50458-650 N 50458-650-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;37.5MG
Approval Date:Aug 15, 2001TE:ABRLD:Yes

Expired US Patents for NDA 021123

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 ➤ Sign Up ➤ Sign Up
Janssen Pharms ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123-001 Aug 15, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Medtronic
Deloitte
Teva
Fuji
US Army
Federal Trade Commission
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Argus Health

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