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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208090

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NDA 208090 describes XTAMPZA ER, which is a drug marketed by Collegium Pharm Inc and is included in one NDA. It is available from two suppliers. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XTAMPZA ER profile page.

The generic ingredient in XTAMPZA ER is oxycodone. There are seventeen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the oxycodone profile page.
Summary for 208090
Tradename:XTAMPZA ER
Applicant:Collegium Pharm Inc
Ingredient:oxycodone
Patents:12
Formulation / Manufacturing:see details
Pharmacology for NDA: 208090
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 208090
Suppliers and Packaging for NDA: 208090
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090 NDA Collegium Pharmaceutical, Inc. 24510-110 N 24510-110-10
XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090 NDA Collegium Pharmaceutical, Inc. 24510-110 N 24510-110-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength9MG
Approval Date:Apr 26, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 26, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Mar 24, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 24, 2025Product Flag?YSubstance Flag?Delist Request?

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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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