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Last Updated: August 11, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201194

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NDA 201194 describes OXYCODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Avanthi Inc, Genus Lifesciences, Lannett Co Inc, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Eywa, Hi Tech, Hikma, Pharm Assoc, Rhodes Pharms, Specgx Llc, Vistapharm, Wockhardt Bio Ag, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Sun Pharm Inds Inc, Vintage Pharms, Barr Labs Inc, and Watson Labs, and is included in fifty NDAs. It is available from thirty-seven suppliers. Additional details are available on the OXYCODONE HYDROCHLORIDE profile page.

The generic ingredient in OXYCODONE HYDROCHLORIDE is ibuprofen; oxycodone hydrochloride. There are sixty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.
Summary for 201194
Tradename:OXYCODONE HYDROCHLORIDE
Applicant:Vistapharm
Ingredient:oxycodone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201194
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 201194
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 201194 NDA VistaPharm, Inc. 66689-401 66689-401-50 5 TRAY in 1 CASE (66689-401-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (66689-401-01)
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 201194 NDA VistaPharm, Inc. 66689-403 66689-403-16 500 mL in 1 BOTTLE (66689-403-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:Jan 12, 2012TE:AARLD:Yes

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Serving leading biopharmaceutical companies globally:

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