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BioPharmaceutical Business Intelligence

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Serving 500+ biopharmaceutical companies globally:

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Generated: September 25, 2017

DrugPatentWatch Database Preview

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 three suppliers. There is one patent protecting this drug and three Paragraph IV challenges. 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. Sixty-seven suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

Summary for NDA: 020281

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 020281

Mechanism of ActionFull Opioid Agonists

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 Lake Erie Medical DBA Quality Care Products LLC 49999-022 49999-022-30 30 TABLET, COATED in 1 BOTTLE (49999-022-30)
ULTRAM
tramadol hydrochloride
 TABLET;ORAL 020281 NDA Lake Erie Medical DBA Quality Care Products LLC 49999-022 49999-022-60 60 TABLET, COATED in 1 BOTTLE (49999-022-60)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Mar 3, 1995TE:RLD:No
Patent:► SubscribePatent Expiration:Apr 12, 2020Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 3, 1995TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Apr 12, 2020Product Flag?Substance Flag?Delist Request?Y


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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Chubb
US Department of Justice
McKesson
Argus Health
Novartis
Fuji
Cerilliant
Johnson and Johnson
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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