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Generated: December 9, 2018

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Details for New Drug Application (NDA): 204092

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NDA 204092 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, 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-five NDAs. It is available from forty-six 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 204092
Tradename:OXYCODONE HYDROCHLORIDE
Applicant:Mayne Pharma Inc
Ingredient:oxycodone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204092
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 204092
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 204092 ANDA Precision Dose, Inc. 68094-801 68094-801-58 50 BAG in 1 CASE (68094-801-58) > 1 SYRINGE in 1 BAG > .5 mL in 1 SYRINGE (68094-801-01)
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 204092 ANDA Mayne Pharma Inc. 68308-020 68308-020-03 1 BOTTLE, PLASTIC in 1 CARTON (68308-020-03) > 30 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/5ML
Approval Date:Jun 5, 2014TE:AARLD:No

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