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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 seventeen drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. There are seventeen tentative approvals for this compound. Additional details are available on the oxycodone hydrochloride profile page.

Summary for NDA: 202080

Egalet Us Inc
oxycodone hydrochloride
Therapeutic Class:Analgesics
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
oxycodone hydrochloride
TABLET;ORAL 202080 NDA Lake Erie Medical DBA Quality Care Products LLC 55700-447 55700-447-30 30 TABLET in 1 BOTTLE (55700-447-30)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 17, 2011TE:RLD:No
Patent:7,201,920Patent Expiration:Mar 16, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:7,510,726Patent Expiration:Nov 26, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:7,981,439Patent Expiration:Nov 26, 2023Product 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.