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Generated: June 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206914

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NDA 206914 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, Hi-tech Pharmacal, Pharm Assoc, Specgx Llc, Vistapharm, Wes Pharma Inc, West-ward Pharms Int, Wockhardt Bio Ag, Actavis Elizabeth, Alvogen Malta, Amneal Pharms, Aurolife Pharma Llc, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Rhodes Pharms, Sun Pharm Inds Inc, Vintage Pharms, Barr Labs Inc, and Watson Labs, and is included in forty-eight NDAs. It is available from forty-five 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 206914
Tradename:OXYCODONE HYDROCHLORIDE
Applicant:Pharm Assoc
Ingredient:oxycodone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206914
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 206914
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 206914 ANDA Pharmaceutical Associates, Inc. 0121-0827 0121-0827-04 118 mL in 1 BOTTLE (0121-0827-04)
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 206914 ANDA Pharmaceutical Associates, Inc. 0121-0827 0121-0827-16 500 mL in 1 BOTTLE (0121-0827-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/ML
Approval Date:Feb 1, 2019TE:AARLD:No

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