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Serving leading biopharmaceutical companies globally:

Argus Health
Harvard Business School
Deloitte
UBS
Merck
Cantor Fitzgerald
Boehringer Ingelheim
Julphar
Mallinckrodt
Express Scripts

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021692

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NDA 021692 describes ULTRAM ER, which is a drug marketed by Valeant Pharms and is included in one NDA. It is available from four suppliers. Additional details are available on the ULTRAM ER profile page.

The generic ingredient in ULTRAM ER is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.
Summary for 021692
Tradename:ULTRAM ER
Applicant:Valeant Pharms
Ingredient:tramadol hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 021692
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 021692
Suppliers and Packaging for NDA: 021692
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692 NDA AUTHORIZED GENERIC Patriot Pharmaceuticals, LLC 10147-0901 10147-0901-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (10147-0901-3)
ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692 NDA AUTHORIZED GENERIC Patriot Pharmaceuticals, LLC 10147-0902 10147-0902-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (10147-0902-3)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Sep 8, 2005TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Sep 8, 2005TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Sep 8, 2005TE:RLD:Yes

Expired US Patents for NDA 021692

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-003 Sep 8, 2005 ➤ Subscribe ➤ Subscribe
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005 ➤ Subscribe ➤ Subscribe
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005 ➤ Subscribe ➤ Subscribe
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-003 Sep 8, 2005 ➤ Subscribe ➤ Subscribe
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-002 Sep 8, 2005 ➤ Subscribe ➤ Subscribe
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-002 Sep 8, 2005 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Chubb
Julphar
Cerilliant
Mallinckrodt
Fish and Richardson
Cantor Fitzgerald
Healthtrust
Express Scripts
Chinese Patent Office

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