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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 eight suppliers. Additional details are available on the ULTRACET profile page.

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

Summary for NDA: 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 STAT Rx USA LLC 16590-230 16590-230-28 28 TABLET, COATED in 1 BOTTLE (16590-230-28)
ULTRACET
acetaminophen; tramadol hydrochloride
TABLET;ORAL 021123 NDA STAT Rx USA LLC 16590-230 16590-230-30 30 TABLET, COATED in 1 BOTTLE (16590-230-30)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 021123

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
ULTRACET
acetaminophen; tramadol hydrochloride
TABLET;ORAL021123-001Aug 15, 20015,336,691► subscribe
Janssen Pharms
ULTRACET
acetaminophen; tramadol hydrochloride
TABLET;ORAL021123-001Aug 15, 2001RE39221► subscribe
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