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Details for New Drug Application (NDA): 090659

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NDA 090659 describes OXYCODONE HYDROCHLORIDE, which is a drug marketed by Novel Labs Inc, Mayne Pharma Inc, Roxane, Vintage Pharms, Alvogen Malta, Ken Lifescience, Lannett Holdings Inc, Lehigh Valley, Actavis Elizabeth, Vistapharm, Amneal Pharms, Wockhardt Bio Ag, Mallinckrodt Inc, Sun Pharm Inds Inc, Aurolife Pharma Llc, Epic Pharma Llc, Avanthi Inc, Ani Pharms Inc, Nesher Pharms, Rhodes Pharms, Corepharma, Barr Labs Inc, and Watson Labs, and is included in thirty-four NDAs. It is available from forty-nine suppliers. Additional details are available on the OXYCODONE HYDROCHLORIDE profile page.

The generic ingredient in OXYCODONE HYDROCHLORIDE is ibuprofen; oxycodone hydrochloride. There are sixty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.

Summary for NDA: 090659

Tradename:
OXYCODONE HYDROCHLORIDE
Applicant:
Sun Pharm Inds Inc
Ingredient:
oxycodone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 090659

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 090659

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
TABLET;ORAL 090659 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-828 35356-828-01 120 TABLET in 1 BOTTLE (35356-828-01)
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
TABLET;ORAL 090659 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-828 35356-828-30 30 TABLET in 1 BOTTLE (35356-828-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 10, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Apr 10, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Apr 10, 2009TE:ABRLD:No


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