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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 four 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-nine suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

Summary for NDA: 020281

Tradename:
ULTRAM
Applicant:
Janssen Pharms
Ingredient:
tramadol hydrochloride
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 49999-022-20 20 TABLET, COATED in 1 BOTTLE (49999-022-20)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Mar 3, 1995TE:RLD:No
Patent:6,339,105*PEDPatent 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:6,339,105*PEDPatent Expiration:Apr 12, 2020Product Flag?Substance Flag?Delist Request?Y


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