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Generated: November 18, 2018

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Details for New Drug Application (NDA): 202080

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NDA 202080 describes OXAYDO, which is a drug marketed by Egalet Us Inc and is included in one NDA. It is available from three suppliers. There are six patents protecting this drug. Additional details are available on the OXAYDO profile page.

The generic ingredient in OXAYDO is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
Summary for 202080
Tradename:OXAYDO
Applicant:Egalet Us Inc
Ingredient:oxycodone hydrochloride
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 202080
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 202080
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXAYDO oxycodone hydrochloride TABLET;ORAL 202080 NDA Lake Erie Medical DBA Quality Care Products LLC 55700-448 55700-448-30 30 TABLET in 1 BOTTLE (55700-448-30)
OXAYDO oxycodone hydrochloride TABLET;ORAL 202080 NDA Pfizer Laboratories Div Pfizer Inc 60793-525 60793-525-01 100 TABLET in 1 BOTTLE (60793-525-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 17, 2011TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Mar 16, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Nov 26, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Nov 26, 2023Product Flag?YSubstance Flag?Delist Request?

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