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Last Updated: January 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203638

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NDA 203638 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, Eywa, Hi Tech, Hikma, Pharm Assoc, Specgx Llc, Vistapharm, Wockhardt Bio Ag, Actavis Elizabeth, Alvogen, 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 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 203638
Tradename:OXYCODONE HYDROCHLORIDE
Applicant:Amneal Pharms
Ingredient:oxycodone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203638
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 203638
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 203638 ANDA Major Pharmaceuticals 0904-6966 0904-6966-61 100 BLISTER PACK in 1 CARTON (0904-6966-61) > 1 TABLET in 1 BLISTER PACK
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 203638 ANDA Direct_Rx 61919-820 61919-820-90 90 TABLET in 1 BOTTLE (61919-820-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 3, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 3, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Jun 3, 2014TE:ABRLD:No

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