Generated: December 13, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 207621
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describes TROXYCA ER
, which is a drug marketed by Pfizer Inc and is included in one NDA. There are two patents protecting this drug. Additional details are available on the TROXYCA ER profile page.
The generic ingredient in TROXYCA ER is naltrexone hydrochloride; oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the naltrexone hydrochloride; oxycodone hydrochloride profile page.
Summary for 207621
|Formulation / Manufacturing:||see details|Complete Access Available with Subscription
Summary for product number 001
|Active Rx/OTC/Discontinued:||DISCN||Dosage:||CAPSULE, EXTENDED RELEASE;ORAL||Strength||1.2MG;10MG|
|Approval Date:||Aug 19, 2016||TE:||RLD:||No|
|Regulatory Exclusivity Expiration:||Aug 19, 2019
|Regulatory Exclusivity Use:||NEW COMBINATION|
|Patent:||► Subscribe||Patent Expiration:||Dec 12, 2027||Product Flag?||Y||Substance Flag?||Delist Request?|
|Patent:||► Subscribe||Patent Expiration:||Jul 3, 2025||Product Flag?||Substance Flag?||Delist Request?|
|Patented Use:||MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED|
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